Orthoscan recalls Ziehm Vision R interventional fluoroscopy systems due to potential unintended X-ray radiation from faulty hand switches after drops or impacts.
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.
Orthoscan recalls Zie:hm Vision R interventional fluoroscopy systems because hand switches might fail after shocks or drops, causing unintended X-ray radiation. This could expose patients or staff to unnecessary radiation risks.
The hand switch may fail when dropped or impacted, damaging its internal component. This could cause the connected X-ray unit to emit radiation unexpectedly, potentially exposing people to unnecessary radiation.
Healthcare professionals using the Ziehm Vision R fluoroscopy systems are most at risk. The recall affects specific serial numbers sold through Orthoscan.
Check for serial numbers: 10295, 10490, 10656, 10716, or 10997. The product is sold by Orthoscan under the brand Ziehm Vision R.
Inspect the hand switch for signs of damage after drops or impacts.
Reach out to Orthoscan directly for specific model and serial number information.
The hand switch may fail after shocks or drops, causing unintended X-ray radiation from the connected X-ray unit.
Check for serial numbers: 10295, 10490, 10656, 10716, or 10997. The product is sold by Orthoscan under the brand Ziehm Vision R.
Inspect the hand switch for damage after drops or impacts. Contact Orthoscan for specific details.
We’ve drafted a message you can send Ziehm Vision to request your refund or repair — edit it as you like.
Subject: Recall Z-0577-2025 — Ziehm Vision Ziehm Vision Hello, I own a Ziehm Vision that is covered by recall Z-0577-2025 from Ziehm Vision. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
