GE Healthcare - GE Healthcare Centricity PACSIW with Universal Viewer - Class 2 Recall
The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2015 Category: Medical Equipment Source Type: alerts
Winco Mfg., LLC - Winco XL Convalescent Recliner with Steel Casters - Class 2 Recall
Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities) (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2015 Category: Medical Equipment Source Type: alerts
Bard Access Systems - PowerPICC SOLO Catheter - Class 3 Recall
PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) The PowerPICC Solo" catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 9, 2015 Category: Medical Equipment Source Type: alerts
Ameda, Inc. - Class 2 Recall
Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2015 Category: Medical Equipment Source Type: alerts
Penner Mfg Inc - Class 2 Recall
Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2015 Category: Medical Equipment Source Type: alerts
Bard Access Systems - Class 2 Recall
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline BARD MYPICC KIT (4F) (Single Lumen), Groshong NXT Catheter 5F Maximal Barrier Tray (Dual-Lumen) (with MicroIntroducer) , Groshong NXT BARD MYPICC KIT (5F) (Dual-Lumen) (45cm), PowerPICC Catheter 5F Full Tray (Single-Lumen), PowerPICC Catheter 5F Maximal Barrier Tray (Single-Lumen), Poly Per-Q-Cath Catheter 3F Single-Lumen ...
Source: Medical Device Recalls - March 14, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Centricity PACS 3.2 - Class 2 Recall
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2015 Category: Medical Equipment Source Type: alerts
Medical Components, Inc dba MedComp - HEMOCATH, SLX, PROPICC, VASCUPICC - Class 2 Recall
Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY), MR81013106MB (3FX60CM SGL TAPRLS VASCU-PICC). Intended uses: To attain long-term vascular access for hemodialysis and apheresis. The Medcomp SLX Silicone Double Lumen Catheter is designed for acute hemodialysis and apheresis. The Pro-PICC¿ CT catheter is indicated for short or long term peripheral access to the central venous system for intra...
Source: Medical Device Recalls - February 11, 2015 Category: Medical Equipment Source Type: alerts
Primus Medical LLC - Prime Care Bed PCB900 - Class 2 Recall
AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 16, 2014 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc - BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - Class 2 Recall
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2014 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc - BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - Class 2 Recall
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2014 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc - BioFlo PICC with ENDEXO Technology and PASV Valve Technology - Class 2 Recall
BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2014 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc - BioFlo PICC with ENDEXO Technology - Class 2 Recall
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2014 Category: Medical Equipment Source Type: alerts
ARJOHUNTLEIGH POLSKA Sp. z.o.o. - Class 2 Recall
Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is accomplished by placing a sling under the patient, and attaching the sling to a spreader bar that is connected to a lifting arm jig via a connection to the spreader bar that allows a swiveling up-down movement. Using battery power, an actuator then powers the lifting arm upwards so that the patient in the sling is ...
Source: Medical Device Recalls - September 25, 2014 Category: Medical Equipment Source Type: alerts
GF Health Products, Inc./d.b.a.Basic American Metal Products - Zenith Slide WIDE Long Term Care Bed - Class 2 Recall
Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 17, 2014 Category: Medical Equipment Source Type: alerts
