Ziehm-orthoscan Inc: Image-intensified Fluoroscopic X-ray System, Mobile
Recall Summary Ziehm-Orthoscan is recalling Orthoscan VERSA Accessory Carts and Versa Mini C-Arm Systems because welds on the cart may not be properly constructed, potentially causing the monitor arm to separate from the cart. The devices were distributed worldwide, including throughout the United States and several other countries. This is a Class II recall, meaning the defect could cause serious health consequences but is unlikely to result in death.
- Recalling firm
- ZIEHM-ORTHOSCAN INC
- Product
- Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
- Reason
- The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-03
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ , CA , CO , CT , FL , GA , IL , IN , KS, MA , MD , MI , MN , NC , NE , NV , NY , OH , OR , SC, TX , UT , WA and the countries of Germany , Australia , Spain , Switzerland, Japan.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/9be5a9c0-e530-4fbf-8a82-da879cc6ff14