In2bones USA, LLC - CoLink(TM) Lapidus Plate XP - Class 2 Recall
CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2018 Category: Medical Devices Source Type: alerts

In2bones USA, LLC - CoLink(TM) Lapidus Plate XP - Class 2 Recall
CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2018 Category: Medical Devices Source Type: alerts

Ortho Kinematics, Inc - Vertebral Motion Analyzer - Class 2 Recall
Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2018 Category: Medical Devices Source Type: alerts

Back 2 Basics Direct LLC - Dymaxeon Spine System - Class 2 Recall
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosi...
Source: Medical Device Recalls - August 22, 2018 Category: Medical Devices Source Type: alerts

LIEBEL-FLARSHEIM COMPANY LLC - LiebelFlarsheim Direct Digital Imaging System (DDIS) - Class 2 Recall
Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2018 Category: Medical Devices Source Type: alerts

LIEBEL-FLARSHEIM COMPANY LLC - LiebelFlarsheim Hydra Vision Urology XRay System (DR) - Class 2 Recall
Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2018 Category: Medical Devices Source Type: alerts

Vyaire Medical - TriFlo'' Subglottic Suction System - Class 1 Recall
The Tri-Flo Subglottic Suction System (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2018 Category: Medical Devices Source Type: alerts

Handicare Usa Inc - Handicare C Series Patient Lift - Class 2 Recall
Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 21, 2018 Category: Medical Devices Source Type: alerts

Handicare Usa Inc - Handicare P600 Series Patient Lift - Class 2 Recall
Handicare P600 Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 21, 2018 Category: Medical Devices Source Type: alerts

Compass Health Brands (Corporate Office) - CPAP Mask Cushion - Class 1 Recall
CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 21, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - Persona Partial Knee System Spacer Block Alignment Tower - Class 2 Recall
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 19, 2018 Category: Medical Devices Source Type: alerts

TriMed Inc. - Ulnar Osteotomy Compression Plate, Short - Class 2 Recall
Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 19, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost 4 Flex / Value - Class 2 Recall
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost 4.1 High Performance - Class 2 Recall
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost 4 Flex / Value - Class 2 Recall
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost Rel.4 Upgrades - Class 2 Recall
DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips EasyDiagnost Eleva DRF - Class 2 Recall
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost Release 3.1 - Class 2 Recall
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost Classic 1.x Upgrades - Class 2 Recall
DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost 4.1 Flex / Value - Class 2 Recall
DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost 4 Chest / Emergency - Class 2 Recall
DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost Single Detector - Class 2 Recall
DigitalDiagnost Single Detector (Stitching Patient Support) 712020 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost Release 3 - Class 2 Recall
DigitalDiagnost Release 3 (Stitching Patient Support) 712025 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost Dual Detector - Class 2 Recall
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost 2.x Upgrades - Class 2 Recall
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost 4.1 Chest / Emergency - Class 2 Recall
DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost Release 3.1 - Class 2 Recall
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost Release 3 - Class 2 Recall
DigitalDiagnost Release 3 (Stitching Patient Support) 712025 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips CombiDiagnost R90 - Class 2 Recall
CombiDiagnost R90 (Stitching Patient Support) 709030 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost, SingleDetect - Class 2 Recall
DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost, DualDetector - Class 2 Recall
DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost Dual Detector - Class 2 Recall
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost Classic, DualDetector - Class 2 Recall
DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost 4.1 - Class 2 Recall
DigitalDiagnost 4.1 (Stitching Patient Support) 712225 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost 2.x Upgrades - Class 2 Recall
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips BuckyDiagnost Ceiling System - Class 2 Recall
BuckyDiagnost Ceiling System (Stitching Patient Support) 704031 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips EasyDiagnost Eleva DRF, Release 5 - Class 2 Recall
EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost Upgrades - Class 2 Recall
DigitalDiagnost Upgrades (Stitching Patient Support) 712083 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost 4 High Performance - Class 2 Recall
DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems Gmbh, DMC - Philips DigitalDiagnost 4.1 High Performance - Class 2 Recall
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Becton Dickinson & Co. - BD BBL GCLect Agar - Class 2 Recall
BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Hitachi Medical Systems America Inc - Hitachi Scenaria CT system - Class 2 Recall
Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the SCENARIA can be post processed by the SCENARIA to provide additional information. Post processing capabilities included in the SCENARIA software include CT angiography (CTA), Multiplanar reconstruction (MPR) and volume rendering. Volume datasets acquired by the SCENARIA Phase 3 can be transferred to external devices via a DICOM st...
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Elekta, Inc. - Digital Accelerator - Class 2 Recall
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Biomerieux Inc - bioMrieux VITEK 2 NH ID Test Kit - Class 2 Recall
bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - Antegrade Femoral Connecting Bolt - Class 2 Recall
Connecting Bolt, Model 14-442093 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - 3D TOP Ceiling Stand - Class 2 Recall
3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - 3D V Ceiling Stand - Class 2 Recall
3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

GE Healthcare Japan Corporation - GE Healthcare Optima CT540 - Class 2 Recall
GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA 540, CT BEIJING OPTIMA 540 ASIR, CT GOLDSEAL OPTIMA 540, CT OPTIMA 540, CT OPTIMA 540 ASIR, CT OPTIMA CT540 TANG BEIJING, DISCOVERY 670 3/8 MEA PRO, HINO OPTIMA 540, HINO OPTIMA 540 ASIR, HINO OPTIMA 540 ASIR, OPTIMA 540, OPTIMA 540 ASIR, OPTIMA 540 MOBILE BEIJING, OPTIMA CT540, OPTIMA CT540 32 SLICES, OPTIMA CT540 ASIR, OPTIMA CT540 BJG SKD RUSSIA, O...
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

GE Healthcare Japan Corporation - GE Healthcare Optima CT660 - Class 2 Recall
GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only outside the U.S. under the following product names: CT OPTIMA 660, CT OPTIMA 660 LONG BJG SKD RUS, CT OPTIMA 660 LONG BJG SKD RUSSIA, CT OPTIMA 660 MID BJG SKD RUSSIA, CT OPTIMA 660 SE, CT OPTIMA 660 SE ASIR, CT660 M40 LONG, CT660 M40 MID, CT660 M40 MID WAUK SKD, CT660 M40 MID WAUK SKD BRAZ, CT660 M40 MID WAUK SKD BRAZ, OPT 660 M40 MID HINO SKD RUS, OPTIMA 660, OPTIMA 660 1.5, OPTIMA 660 1.5 BRAZIL, OPTIMA 660 1.5 BRAZIL SKD W, OPTIMA 660 1.5 BRAZIL SKD WAUK, OPTIMA 660 LONG BJG,...
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts

GE Healthcare Japan Corporation - GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680 - Class 2 Recall
GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT OPTIMA 660 M40 GT1700, CT OPTIMA 660 M40 GT1700 BEIJI, CT OPTIMA 660 M40 GT1700 HINO, CT OPTIMA 660 M40 GT2000 BEIJI, CT OPTIMA 660 M40 GT2000 HINO, CT OPTIMA CT 660, CT OPTIMA CT660, CT OPTIMA CT660 M4, CT OPTIMA CT660 M40, CT REVOLUTION EVO 3.5 LONG HIN, CT REVOLUTION EVO VT2000 HINO, CT660 MAR UPGRADE, MOBILE OPTIMA CT 660, O...
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts