Orthoscan recalls Ziehm Vision RFD interventional fluoroscopy systems due to risk of unintended radiation from a hand switch that can fail if dropped or impacted.
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 Ziehm Vision RFD interventional fluoroscopy systems because their wired hand switches might fail if dropped or hit, potentially causing unintended X-ray radiation. This could expose patients or staff to unnecessary radiation during procedures.
The hand switch can become irreversibly damaged if subjected to shocks or impacts, like dropping it. This damage might cause the system to emit radiation unexpectedly during procedures, potentially exposing patients or staff to unnecessary radiation.
Healthcare professionals using the Ziehm Vision RFD interventional fluoroscopy systems are most at risk. Patients undergoing procedures with these systems may also be exposed to unintended radiation.
Check for the serial numbers listed: 20048, 20240, 23805, 21350, 23249, 23250, 23251, 23252, 23253, 23324, 23375, 23376, 23377, 23378, 23379, 23380, 23381, 23382, 23412, 23452, 23460, 23461, 23462, 23463, 23506, 23536, 23721, 23737, 23738, 23739. The product is sold under the brand Ziehm Vision.
Inspect the hand switch for signs of damage, such as cracks or loose parts, which could indicate it has been impacted.
Reach out to Orthoscan or Ziehm Imaging for specific guidance on whether your unit needs repair or replacement.
The hand switch may fail if dropped or hit, potentially causing unintended radiation during procedures.
Check the serial numbers listed: 20048, 20240, 23805, 21350, 23249, 23250, 23251, 23252, 23253, 23324, 23375, 23376, 23377, 23378, 23379, 23380, 23381, 23382, 23412, 23452, 23460, 23461, 23462, 23463, 23506, 23536, 23721, 23737, 23738, 23739.
No, but you should check the hand switch for damage and contact Orthoscan for guidance.
We’ve drafted a message you can send Ziehm Vision to request your refund or repair — edit it as you like.
Subject: Recall Z-0578-2025 — Ziehm Vision Ziehm Vision Hello, I own a Ziehm Vision that is covered by recall Z-0578-2025 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.
