Ziehm Solo FD. Interventional fluoroscopic x-ray system
This recall is currently active, issued December 2, 2024. It was issued by Orthoscan, Inc..
- Company
- Orthoscan, Inc.
- Recall Initiated
- August 8, 2024
- Posted
- December 2, 2024
- Recall Number
- Z-0574-2025
- Quantity
- 25
- Firm Location
- Scottsdale, AZ
- Official Source
- View on FDA website ↗
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.
Distribution
U.S. (including Puerto Rico).
Lot / Code Info
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.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Ziehm Imaging, Inc. intends to notify the affected customers directly in the following manner: 1) Letter with return receipt requested, envelope, return, and reply to questionnaire, or E-mail contact. 2) Direct phone calls. Once contact is made and confirmed Ziehm Imaging Inc, shall provide replacement hand switch and instructions to the end user. Wired Hand switch 88036 Vl.02 will be requested to be returned by the customer/end user to Ziehm Imaging Inc. and will be subjected to be scrapped.