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FORE-SIGHT ELITE Absolute Oximeter (Edwards) – Inaccurate Tissue Reading (2022)

The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment

FDAMar 1, 2022Nationwide• Edwards Lifesciences, LLC

Access-9 Hemostasis Valves (Merit) – Guidewire Gap Risk (2022)

A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in difficulty advancing the guidewire through the device. This defect may result in a delay of procedure.

FDAMar 1, 2022AL, AK, AZ +46 more

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FORE-SIGHT ELITE Absolute Oximeter (Edwards) – Inaccurate Tissue Reading (2022)

Access-9 Hemostasis Valves (Merit) – Guidewire Gap Risk (2022)

Philips Respironics V60 Ventilator (Respironics) – Electrical Circuit Risk (2022)

NanoSight LM10 (Malvern Panalytical) – Laser Safety Non-Compliance (2022)

Philips Respironics V60 Plus Ventilator (Respironics) – Electrical Circuit Risk (2022)

Medtronic InterStim Therapy System (Medtronic) – Software Data Issue (2022)

Integra Universal Flexible Arm (Integra) – Internal Cable Breakage (2022)

Philips Respironics V680 Ventilator (Respironics) – Electrical Circuit Risk (2022)

syngo Application Software (Siemens) – Image Mirroring Risk (2022)

Baxter DISCPAC Syringe Tip Caps (Baxter) – Mislabeling Issue (2022)

Anterior Hip Pack (Stradis) – Sterility Breach Risk (2022)

Coryell Memorial Joint Pack (Stradis) – Sterility Breach Risk (2022)

Artis icono Biplane (Siemens) – Multiple Software Issues (2022)

Artis pheno System (Siemens) – Multiple Software Issues (2022)

therascreen KRAS PCR Kit (Qiagen) – Mutation Result Uncertainty (2022)

Surgicare Neuro Pack (Stradis) – Sterility Breach Risk (2022)

Lum Lam Custom Pack (Stradis) – Sterility Breach Risk (2022)

Celltrion COVID-19 Ag Test (Celltrion) – Incorrect Expiration Date (2022)

ExacTrac Dynamic Software (Brainlab) – Positioning Angle Error (2022)

MiniCap PD Transfer Set (Baxter) – Regulatory Clearance Missing (2022)