Philips Medical Systems (Cleveland) Inc - Philips Ingenuity Core 128 - Class 2 Recall
Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - Siemens Biograph mCT - Class 2 Recall
Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20)-3R, Material Number 10534159 h) mCT Flow Edge-4R, Material Number 10528955 i) mCT Flow 40-3R, Material Number 10529158 j) mCT Flow 64-3R, Material Number 10529160 k) mCT X-4R, Material Number 10248670 l) mCT X-3R, Material Number 10248673 m) mCT S(20)-4R, Material Number 10534160 n) mCT S(40)-3R, Material Number 10248668 o) mCT Flow 40-4R, Material Number 10...
Source: Medical Device Recalls - October 19, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - Siemens Biograph Horizon - Class 2 Recall
Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 19, 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 s...
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,...
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, ...
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips IQon Spectral CT with softare version 4.7 - Class 2 Recall
IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Healthcare Brilliance 64 - Class 2 Recall
Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 13, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Healthcare 16P - Class 2 Recall
Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 13, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Healthcare Brilliance 16 - Class 2 Recall
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 13, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - Biograph mCT Systems: - Class 2 Recall
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceutical...
Source: Medical Device Recalls - June 9, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM definition AS - Class 2 Recall
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Definition Flash - Class 2 Recall
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Definition Force - Class 2 Recall
SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2018 Category: Medical Devices Source Type: alerts
