FDA recall, , Moderate risk
Ziehm-Orthoscan VERSA Accessory Cart and Versa Mini C-Arm System
The accessory cart and mini C-arm system have a weld that may fail, causing the monitor arm to separate.
Summary by Recall Canary from the FDA notice
What happened
ZIEHM-ORTHOSCAN INC is recalling the Orthoscan VERSA Accessory Cart, REF: 1000-0021, and the Versa Mini C-Arm System, REF: 1000-0020, because the accessory cart weldment does not conform to weld dimensional specifications. This may result in separation of the monitor arm mounting structure from the cart. The company began the recall on September 3, 2026, and the FDA added it to its Enforcement Report on October 23, 2026.
The recall affects 55 units distributed worldwide, including in the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, Nevada, New York, Ohio, Oregon, South Carolina, Texas, Utah and Washington, and the countries of Germany, Australia, Spain, Switzerland and Japan.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Arizona , California , Colorado , Connecticut , Florida , Georgia , Illinois , Indiana , Kansas, Massachusetts , Maryland , Michigan , Minnesota , North Carolina , Nebraska , Nevada , New York , Ohio , Oregon , South Carolina, Texas , Utah , Washington and the countries of Germany , Australia , Spain , Switzerland, Japan.
- Company
- ZIEHM-ORTHOSCAN INC
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99979
- Recall number
- Z-0286-2027
- Quantity recalled
- 55 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
