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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

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)

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

High

FDAMay 19, 2023Nationwide

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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)

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)

TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter (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)

DigitalDiagnost C90, Model No. 712034 and 712035 (Philips North America Llc) – there is a software login in issue th... (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)

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

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

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

VITROS NT-proBNP II (Ortho-Clinical) – Stability Specification (2023)

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

Medline Probe Cover Kits (Medline) – Barrier Seam Inadequacy (2023)

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

MEDLINE PVP Solution (Medline) – Mislabeling Issue (2023)

QUADROX-iD Pediatric (Maquet) – Packaging Pinhole Risk (2023)

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

Allen Advance Chest Support (Baxter) – Potential Cracking (2023)

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