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

Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

FDAFeb 28, 2022Nationwide• Respironics California, LLC

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

Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

FDAFeb 28, 2022Nationwide• Respironics California, LLC

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

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

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

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

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

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

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

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

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

DigitalDiagnost C50 (Philips) – Incorrect Height Setting (2022)

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

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

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

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

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

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

Total Knee Pack (Stradis) – Sterility Breach Risk (2022)

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

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

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