Recall Z-0286-2027 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
ZIEHM-ORTHOSCAN INC
Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
| Date | Oct 23, 2026 (initiated Sep 3, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On September 11, 2026, Ziehm-Orthoscan issued a Urgent: Medical Device Recall Notification via Email. Ziehm-Orthoscan ask consignees to take the following actions: 1. The device may continue to be used until the corrective action has been completed, provided the user follows the precautions described in this notification and no signs of instability or unintended movement are observed. 2. Users should exercise caution when positioning, moving, or operating the system and monitor assembly, avoid fully extending the display arm until the corrective action has been performed. 3. If unintended m |
| Quantity | 55 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243452 | Orthoscan VERSA Mini C-Arm Ziehm-Orthoscan, Inc., Jan 14, 2025 |