All Recalls

95,050 total recalls in our database

πŸ₯ Medical Devices Class I - Dangerous

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Jun 6, 2019 Other Medical Devices Nationwide View Details β†’

The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.

May 28, 2019 Infusion Pumps Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Jun 6, 2019 Other Medical Devices Nationwide View Details β†’

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Apr 8, 2019 Diagnostic Equipment Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.

Jun 4, 2019 Other Medical Devices View Details β†’

Potential for reporting low assay results

May 10, 2019 Surgical Instruments Nationwide View Details β†’

The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.

May 28, 2019 Infusion Pumps Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Jun 6, 2019 Other Medical Devices Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Jun 6, 2019 Other Medical Devices Nationwide View Details β†’

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Apr 8, 2019 Diagnostic Equipment Nationwide View Details β†’

The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/or protrusion of the cover into the bore diameter.

Jun 3, 2019 Diagnostic Equipment Nationwide View Details β†’

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Apr 8, 2019 Diagnostic Equipment Nationwide View Details β†’

The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.

May 28, 2019 Infusion Pumps Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Jun 6, 2019 Other Medical Devices Nationwide View Details β†’

The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.

Jun 4, 2019 Infusion Pumps Nationwide View Details β†’

Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.

Sep 24, 2018 Other Medical Devices View Details β†’

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Apr 8, 2019 Diagnostic Equipment Nationwide View Details β†’