Orthoscan, Inc. recalls Ziehm Solo. Digital Mobile C-arm
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…
Read the official notice →- Date
- 2024-12-11
- Country
- United States
- Brand
- Orthoscan, Inc.
- Product
- Ziehm Solo. Digital Mobile C-arm
- Classification
- Class II
- Units
- U.S. (including Puerto Rico).
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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