Ziehm Imaging Inc

Complete recall history across all FDA and CPSC categories — 14 total recalls

Ziehm Imaging Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (14)

FDA medical device enforcement actions by Ziehm Imaging Inc

Date Product Reason Class
Feb 23, 2017 Ziehm Imaging solo FD Mobile Fluoroscopic C-arm During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-... Class II
Apr 15, 2016 Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warni... Class II
Apr 15, 2016 Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warni... Class II
Apr 15, 2016 Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warni... Class II
Apr 15, 2016 Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warni... Class II
Apr 15, 2016 Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warni... Class II
Apr 15, 2016 Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warni... Class II
Nov 21, 2013 Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fl... Engineering change in 2006 resulted in a minor non-conformity of their device... Class II
Nov 21, 2013 Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Flu... Engineering change in 2006 resulted in a minor non-conformity of their device... Class II
Nov 21, 2013 Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoro... Engineering change in 2006 resulted in a minor non-conformity of their device... Class II
Nov 21, 2013 Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile ... Engineering change in 2006 resulted in a minor non-conformity of their device... Class II
Nov 21, 2013 Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluorosc... Engineering change in 2006 resulted in a minor non-conformity of their device... Class II
Nov 21, 2013 Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mob... Engineering change in 2006 resulted in a minor non-conformity of their device... Class II
Nov 21, 2013 Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Flu... Engineering change in 2006 resulted in a minor non-conformity of their device... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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