FDA Medical devices recall ·
Ziehm Solo FD. Interventional fluoroscopic x-ray system recall
- Recall number
- Z-0574-2025
- Date
- (initiated August 8, 2024)
- Company / brand
- Orthoscan, Inc.
14555 N 82nd St, Scottsdale, AZ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 25
- Hazard tags
- Electrical shock
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Ziehm Solo FD. Interventional fluoroscopic x-ray system
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: EZIEZIEHMSOLOFD1 Serial Numbers: 54301, 54772, 54773, 54774, 54792, 54793, 54794, 54795, 54796, 54797, 54798, 54851, 54852, 54855, 55020, 55021, 55114, 55115, 55116, 55117, 55118, 55119, 55120, 55121, 55212.
Distribution
U.S. (including Puerto Rico).
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0574-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.