Ziehm Vision system recall
Ziehm Vision system, x-ray, tomography, computed.
Why was Ziehm Vision system recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: EZIEZIEHMVISIONFD1 Serial Numbers: 9246, 90155, 90416.
- Product
- Ziehm Vision system, x-ray, tomography, computed.
- Recalling firm
- Orthoscan, Inc.
- Quantity
- 3
- Distribution
- U.S. (including Puerto Rico).
- Recall date
- December 11, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)