Orthoscan recalls Ziehm Solo FD interventional fluoroscopy systems with serial numbers 54301-55212 due to risk of unintended radiation from a faulty hand switch that can fail when 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 Solo FD interventional fluoroscopy systems with specific serial numbers because the hand switch 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 may become irreversibly damaged if subjected to shocks or impacts like dropping. This defect could cause the connected X-ray unit to emit radiation unexpectedly during procedures.
Healthcare professionals using the Ziehm Solo FD system with the listed serial numbers are most at risk. Patients undergoing procedures with this equipment could also be exposed to unintended radiation.
Check the serial number on the device, which is listed in the recall notice: 54301 through 55212. The product is an interventional fluoroscopic X-ray system made by Ziehm Imaging GmbH.
Look for the serial number on the device, which should be one of the listed numbers: 54301, 54772, 54773, 54774, 54792, 54793, 54794, 54795, 54796, 54797, 54798, 54851, 54852, 54855, 55020, 55021, 55114, 55115, 55116, 55117, 55118, 55119, 55120, 55121, 55212.
The hand switch may fail if dropped or hit, potentially causing unintended radiation from the X-ray unit during procedures.
Check the serial number against the list provided in the recall notice. If it matches, stop using the device until you can get a replacement or repair.
The recall record does not specify a remedy, so the device should be checked and replaced if it matches the serial numbers listed.
We’ve drafted a message you can send Ziehm to request your refund or repair — edit it as you like.
Subject: Recall Z-0574-2025 — Ziehm Ziehm Hello, I own a Ziehm that is covered by recall Z-0574-2025 from Ziehm. 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.
