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Showing 1381–1400 of 8389 results

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Phasor Drill (Phasor Health) – battery orientation risk (2025)

Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

FDAMar 21, 2025AZ, AR, CA +25 more• Phasor Health, LLC

DuraShock Aneroid Gauge (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

FDAMar 21, 2025Nationwide• Baxter Healthcare Corporation

Spot Vital Signs 4400 (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Low

FDAMar 21, 2025Nationwide• Baxter Healthcare Corporation

CareStation 620 A1 (GE Healthcare) – ventilation ineffective (2025)

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

FDAMar 21, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

Connex Wall System (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

FDAMar 21, 2025Nationwide• Baxter Healthcare Corporation

OEC 3D (GE Medical) – X-ray field distance issue (2025)

OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

FDAMar 21, 2025Nationwide• GE Medical Systems, LLC

Green Series 777 Wall System (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

FDAMar 21, 2025Nationwide• Baxter Healthcare Corporation

Connex Spot Monitor (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

FDAMar 21, 2025Nationwide• Baxter Healthcare Corporation

ABL90 Series (Radiometer) – analyzer freeze risk (2025)

ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.

FDAMar 21, 2025AL, AZ, AR +46 more• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Blood Pressure Cuff Kit (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

FDAMar 21, 2025Nationwide• Baxter Healthcare Corporation

CareStation 650C A1 (GE Healthcare) – ventilation ineffective (2025)

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

FDAMar 21, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

CareStation 750 A1 (GE Healthcare) – ventilation ineffective (2025)

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

FDAMar 21, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

Connex Vital Signs Monitor (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

FDAMar 21, 2025Nationwide• Baxter Healthcare Corporation

CareStation 750c A1 (GE Healthcare) – ventilation ineffective (2025)

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

FDAMar 21, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

OEC Elite (GE Medical) – X-ray field distance issue (2025)

OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

FDAMar 21, 2025Nationwide• GE Medical Systems, LLC

CareStation 650 A1 (GE Healthcare) – ventilation ineffective (2025)

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

FDAMar 21, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

VASOVIEW HEMOPRO 2 (Maquet) – ceramic C-Ring breakage (2025)

There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.

FDAMar 20, 2025Nationwide• Maquet Cardiovascular, LLC

Cerene Cryotherapy Device (Channel Medsystems) – gasket seal issue (2025)

Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device

FDAMar 20, 2025Nationwide• Channel Medsystems, Inc.

GenetiSure Dx Kit (Agilent) – DNA labeling component (2025)

DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable genetic disorder.

FDAMar 20, 2025MA• Agilent Technologies, Inc.

Alinity m System (Abbott Molecular) – liquid waste risk (2025)

The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.

FDAMar 20, 2025Nationwide• Abbott Molecular, Inc.

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