Recall Z-0576-2025 ยท OWB Interventional Fluoroscopic X-Ray System
Orthoscan, Inc.
Ziehm Vision FD. Interventional fluoroscopic x-ray system
| Date | Dec 2, 2024 (initiated Aug 8, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 22 |
| Distribution | U.S. (including Puerto Rico). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K240020 | Ziehm Vision FD Ziehm Imaging GmbH, Jan 30, 2024 |