Orthoscan, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0576-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Ziehm Vision FD. Interventional fluoroscopic x-ray system

Product Classification:

Class II

Date Initiated: August 8, 2024

Date Posted: December 11, 2024

Recall Number: Z-0576-2025

Event ID: 95709

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 22

Code Information:

UDI: EZIEZIEHMVISIONFD1651 Serial Numbers: 93412, 93443, 93451, 93452, 93461, 93483, 93485, 93486, 93503, 93619, 93620, 93621. 93622 93623 93628 93629 93660 93661 93662 93626 93625 93627

Distribution Pattern:

U.S. (including Puerto Rico).

Voluntary or Mandated:

FDA Mandated