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Cios Alpha C-arm (Siemens) – Software Update (2023)

Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

High

FDASep 12, 2023Nationwide• Siemens Medical Solutions USA, Inc

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

Moderate

FDASep 12, 2023Nationwide• Olympus Corporation of the Americas

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Cios Alpha C-arm (Siemens) – Software Update (2023)

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

BACTEC Culture Vials (Becton Dickinson) – Barcode Duplication (2023)

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Spetzler-Malis Forceps (Stryker) – Expiration Labeling (2023)

Sapphire Infusion Pumps (Eitan Medical) – Air Detection Failure (2023)

Burn Pack (ROi CPS) – Dermatome Blade Issue (2023)

Omega Monitor Suspension (Omega Medical) – Boom Detachment (2023)

Centricity Viewer Workflow Manager (GE Healthcare) – Exam Launch Issue (2023)

Universal Viewer Workflow Manager (GE Healthcare) – Exam Launch Issue (2023)

F2-01 Patient Monitor (GE Medical) – Data Communication Interruption (2023)

Alcon Custom-Pak (Alcon) – Latex Mislabeling (2023)

CORI RI.KNEE Software (Blue Belt) – Planning Stage Missing (2023)

Fogarty Embolectomy Catheter (Edwards) – Balloon Deflation (2023)

2008T Hemodialysis System without CDX (Fresenius) – PCBA leaching risk (2023)

Hemodialysis System (Fresenius) – Tubing Leaching (2023)

RX Daytona Plus Clinical Chemistry Analyzer (Randox) – rerun settings issue (2023)

RX Modena Clinical Chemistry Analyzer (Randox) – rerun settings issue (2023)

2008T Hemodialysis System w/Bibag (Fresenius) – PCBA leaching risk (2023)

Hemodialysis System (Fresenius) – Tubing Leaching (2023)