Orthoscan recalls Ziehm Vision FD interventional fluoroscopy systems with serial numbers 93412-93662. Defective hand switches could cause unintended X-ray radiation 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 FD interventional fluoroscopy systems that may have faulty hand switches. If dropped or hit, these switches could cause unintended X-ray radiation exposure.
The hand switch may fail when dropped or impacted, damaging the switching element. This could cause the connected X-ray unit to emit radiation unexpectedly during procedures.
Medical professionals using the Ziehm Vision FD systems with serial numbers 93412-93662 are most at risk. Patients and staff could be exposed to unintended radiation if the system malfunctions.
Check for serial numbers 93412 through 93662 on the Ziehm Vision FD system. The product was sold by Orthoscan, Inc. in the U.S. between 2019 and 2023.
Look for serial numbers 93412-93662 on the Ziehm Vision FD system.
The hand switch may fail when dropped or impacted, causing unintended radiation exposure.
Check for serial numbers 93412 through 93662 on the Ziehm Vision FD system.
The recall does not specify a remedy, so 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-0576-2025 — Ziehm Vision Ziehm Vision Hello, I own a Ziehm Vision that is covered by recall Z-0576-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
