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Ziehm Solo FD X-ray System (Orthoscan) - Device Requirements Gap (2024)

Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

High

FDAAug 8, 2024PR• Orthoscan, Inc.

Blood Pressure Module BPM3 (Fresenius) - Measurement Recording Issue (2024)

Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.

Moderate

FDAAug 8, 2024Nationwide

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Ziehm Solo FD X-ray System (Orthoscan) - Device Requirements Gap (2024)

Blood Pressure Module BPM3 (Fresenius) - Measurement Recording Issue (2024)

CardioSave Hybrid Balloon Pump (Datascope) - Software Correction (2024)

Ziehm Vision RFD X-ray System (Orthoscan) - Device Requirements Gap (2024)

Eakin Cohesive Seal (T.G. Eakin) - Incorrect Label Risk (2024)

ViewPoint 6 System (GE Healthcare) - Cybersecurity Vulnerability (2024)

Ziehm Solo C-arm (Orthoscan) - Device Requirements Gap (2024)

Ziehm Vision R X-ray System (Orthoscan) - Device Requirements Gap (2024)

Anesthesia Extension Set (B. Braun) - Connector Leakage Risk (2024)

Philips Allura Xper System (Philips) - Bolt Placement Error (2024)

Vaginal Delivery ASDV25B (American Contract Systems) – Humidity Issue (2024)

IR Procedure Pack (American Contract) - Humidity Control Failure (2024)

Neuro Vascular Kit (American Contract) - Humidity Control Failure (2024)

Cysto FTCY03L (American Contract Systems) – Humidity Issue (2024)

Essentia Laparotomy Pack (American Contract) - Humidity Control Failure (2024)

FilmArray Torch Module (BioFire) - Calibration Equipment Problem (2024)

Pacemaker Kit (American Contract) - Humidity Control Failure (2024)

Hand Pack AKHD97C (American Contract Systems) – Humidity Issue (2024)

ENT COEN27N (American Contract Systems) – Humidity Issue (2024)

Biodesign Recto-Vaginal Fistula Plug RVP-0.2 (Cook Biotech) – Early Expiration (2024)