Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered October 31, 2017 between United States of America and Philips North America
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the pedestal location and buffers the pedestal movement history.
Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
Arrow International
Class I - Dangerous
These finished good kits may contain the incorrect Springwire Guide (SWG).
Class I - Dangerous
These finished good kits may contain the incorrect Springwire Guide (SWG).
Class I - Dangerous
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018
Arrow International
Class I - Dangerous
These finished good kits may contain the incorrect Springwire Guide (SWG).
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
ZIMMER ORTHOPEDIC MFG
Class I - Dangerous
There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
Arrow International
Class I - Dangerous
The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Roche Diagnostics
Class I - Dangerous
A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
Class I - Dangerous
FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
Class I - Dangerous
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Class I - Dangerous
FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018
Arrow International
Class I - Dangerous
These finished good kits may contain the incorrect Springwire Guide (SWG).
Class I - Dangerous
Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
Allen Medical Systems
Class I - Dangerous
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value