Recall Z-0286-2027— ZIEHM-ORTHOSCAN INC
Class II · Ongoing
Class II FDA medical device recall by ZIEHM-ORTHOSCAN INC, initiated 2026-09-03. It names one FDA 510(k) clearance: K243452. 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..
- Recalling firm
- ZIEHM-ORTHOSCAN INC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-03
- Firm location
- Scottsdale, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.