Orthoscan recalls Ziehm Solo Digital Mobile C-arm units with serial numbers starting with 50652-55226 due to potential hand switch failure from shocks, risking unintended X-ray radiation. Affected units must be checked for serial numbers listed.
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 Digital Mobile C-arm units with specific serial numbers because the hand switch might fail if dropped or hit, which could cause the X-ray unit to emit radiation unexpectedly. This poses a risk of unintended radiation exposure during medical procedures.
The hand switch may become damaged if the device is dropped or hit, causing it to send unintended electrical signals to the X-ray unit. This could lead to the X-ray unit activating without proper control, potentially exposing people to radiation.
Medical facilities using the Ziehm Solo Digital Mobile C-arm with serial numbers listed in the recall are most at risk. Patients and staff during X-ray procedures could be exposed to unintended radiation if the device malfunctions.
Check the serial number on the device, which starts with 50652 or higher up to 55226. The recall includes specific serial numbers listed in the official notice.
Look for the serial number on the device, which starts with 50652 through 55226.
The hand switch may fail if the device is dropped or hit, potentially causing unintended radiation from the X-ray unit.
Check the serial number to see if it's in the list of affected units (50652-55226). If affected, contact Orthoscan for further instructions.
The recall addresses potential unintended radiation exposure during medical procedures, not direct injury from the device itself.
We’ve drafted a message you can send Ziehm to request your refund or repair — edit it as you like.
Subject: Recall Z-0573-2025 — Ziehm Ziehm Hello, I own a Ziehm that is covered by recall Z-0573-2025 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.
