Orthoscan recalls Ziehm Vision X-ray systems with serial numbers 9246, 90155, 90416 due to hand switch failure risk from shocks or drops, potentially causing unintended X-ray radiation.
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 specific Ziehm Vision X-ray systems that may have a hand switch prone to failure when dropped or hit. This could lead to unintended X-ray radiation exposure if the switch malfunctions.
The hand switch in the X-ray system may become damaged from shocks or drops. If damaged, it could trigger unintended X-ray radiation emissions from the mobile unit.
Healthcare professionals using the recalled Ziehm Vision X-ray systems are most at risk. Patients using these systems could also be exposed to unintended radiation if the hand switch fails.
Check for serial numbers 9246, 90155, or 90416 on the Ziehm Vision X-ray system. The product was sold by Orthoscan, Inc. with UDI code EZIEZIEHMVISIONFD1.
Inspect the hand switch for signs of damage from shocks or drops.
Reach out to Orthoscan, Inc. for specific guidance on handling the recalled units.
The hand switch may fail under mechanical stress like drops or impacts, potentially causing unintended X-ray radiation.
Check for serial numbers 9246, 90155, or 90416 and contact Orthoscan, Inc. for further instructions.
The recall addresses potential unintended X-ray radiation exposure, not direct injury from the device itself.
We’ve drafted a message you can send Ziehm Vision to request your refund or repair — edit it as you like.
Subject: Recall Z-0575-2025 — Ziehm Vision Ziehm Vision Hello, I own a Ziehm Vision that is covered by recall Z-0575-2025 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.
