[Recalled] Ziehm Vision RFD. Interventional fluoroscopic x-ray system — Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Ima… | FDA 2024-08-08

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Orthoscan, Inc.

• Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. — Class II
• Ziehm Solo. Digital Mobile C-arm — Class II
• Ziehm Solo FD. Interventional fluoroscopic x-ray system — Class II
• Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. — Class II
• Ziehm Vision system, x-ray, tomography, computed. — Class II
• Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.