Official recall record
Ziehm Solo FD. Interventional fluoroscopic x-ray system
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-08-08
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Orthoscan, Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2024-08-08 · US FDA — Medical Devices
Ziehm Solo. Digital Mobile C-arm - 2024-08-08 · US FDA — Medical Devices
Ziehm Vision RFD. Interventional fluoroscopic x-ray system - 2024-08-08 · US FDA — Medical Devices
Ziehm Vision system, x-ray, tomography, computed.