Orthoscan recalls Ziehm Vision RFD 3D fluoroscopy systems with serial numbers listed. 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 RFD 3D fluoroscopy systems due to a risk that hand switches might fail if dropped or hit, potentially causing unintended X-ray radiation. This could affect medical staff using the equipment during procedures.
The hand switch could become irreversibly damaged if dropped or impacted, leading to unintended radiation from the X-ray unit. This happens because the switch fails to properly control the X-ray emission when mechanical stress occurs.
Medical professionals using the Ziehm Vision RFD 3D fluoroscopy system for X-ray procedures are most at risk. Patients and staff in healthcare facilities that use these systems may be affected.
Check for serial numbers listed in the recall: 21118, 21212, 22040, 22710, 22764, 23247, 23248, 23255, 23257, 23258, 23259, 23260, 23327, 23328, 23329, 23456, 23457, 23458, 23459, 23653, 23654, 23655, 23656, 23657, 23666, 23667, 23668, 23669, 23670, 23671, 23672, 23673, 23674, 23723, 23740, 23744, 23745, 23746, 23747, 23748, 23749, 23750, 23751, 23752, 23753, 23775, 23801, 23802, 23828, 23849.
Inspect the hand switch for signs of damage or looseness after any drop or impact.
Confirm your device's serial number matches the list provided in the recall notice.
The hand switch may fail if dropped or impacted, potentially causing unintended X-ray radiation from the connected X-ray unit.
Check if your device's serial number is in the list provided. If it is, inspect the hand switch for damage and contact Orthoscan for guidance.
The recall record does not specify a remedy, so no immediate fix is provided. Contact Orthoscan for further instructions.
We’ve drafted a message you can send Ziehm Vision to request your refund or repair — edit it as you like.
Subject: Recall Z-0579-2025 — Ziehm Vision Ziehm Vision Hello, I own a Ziehm Vision that is covered by recall Z-0579-2025 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.
