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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

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

Product found to not comply to Class 1 Laser safety requirement.

FDAFeb 28, 2022Nationwide• MALVERN PANALYTICAL LTD Grovewood Road Malvern United Kingdom

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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