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TruSignal Ear Sensor, REF TS-E-D; Oximeter (GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland) – there is a potential reduction of ene... (2023)

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

High

FDAMay 19, 2023Nationwide• GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland

Beside panel FRU (Field Replacement Units) Kits (DATEX--OHMEDA, INC.) – ge healthcare has become aware of the... (2023)

GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices

Low

FDAMay 19, 2023Nationwide• DATEX--OHMEDA, INC.

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TruSignal Ear Sensor, REF TS-E-D; Oximeter (GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland) – there is a potential reduction of ene... (2023)

Beside panel FRU (Field Replacement Units) Kits (DATEX--OHMEDA, INC.) – ge healthcare has become aware of the... (2023)

UroPass Ureteral Access Sheaths, 5 pieces/box (Olympus Corporation of the Americas) – dilator tips may break in the package... (2023)

Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.4... (Baxter Healthcare Corporation) – baxter identified a potential risk wh... (2023)

Giraffe OmniBed, with the following Model Numbers: 6650-0... (DATEX--OHMEDA, INC.) – ge healthcare has become aware of the... (2023)

TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) RE... (GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland) – there is a potential reduction of ene... (2023)

NaviCare Patient Safety V3.9.200 to 3.9.600, used with th... (Baxter Healthcare Corporation) – baxter identified a potential risk wh... (2023)

QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitati... (Qiagen GmbH Qiagen Str. 1 Hilden Germany) – identified a decreased performance re... (2023)

Giraffe OmniBed Carestation CS1, Model Numbers: a. 208... (DATEX--OHMEDA, INC.) – ge healthcare has become aware of the... (2023)

TruSignal Integrated Ear Sensor with GE Connector REF TS-... (GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland) – there is a potential reduction of ene... (2023)

ARROW Endurance Extended Dwell Peripheral Catheter System (ARROW INTERNATIONAL Inc.) – potential for catheter separation or ... (2023)

TruSignal Wrap Sensor, REF TS-W-D; Oximeter (GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland) – there is a potential reduction of ene... (2023)

TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) R... (GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland) – there is a potential reduction of ene... (2023)

Contour next GEN Blood Glucose Monitoring System (Ascensia Diabetes Care US, Inc.) – ascensia diabetes care has determined... (2023)

QUADROX-i Neonatal (Maquet) – Packaging Pinhole Risk (2023)

QUADROX-iR (Maquet) – Packaging Pinhole Risk (2023)

Aesculap Surgical Needle (Aesculap) – Product Code Mismatch (2023)

QUADROX-iD (Maquet) – Packaging Accessory Damage (2023)

QUADROX-i Neonatal (Maquet) – Packaging Accessory Damage (2023)

QUADROX-i Adult (Maquet) – Packaging Accessory Damage (2023)