FDA-Device2026-10-23Class IIPROCESSING DEFECT
Ziehm Orthoscan VERSA accessory cart recalled for monitor arm separation risk
What this means
Certain Ziehm Orthoscan VERSA accessory carts and Versa Mini C-Arm systems have welds that do not meet specifications. This defect could cause the monitor arm mounting structure to separate from the cart during use.
- Check your device serial number against the affected list provided by Ziehm Orthoscan
- Contact Ziehm Orthoscan for inspection or replacement instructions
- Do not use affected units until corrective action is completed
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
55 units
Manufactured in
14555 N 82nd St, Scottsdale, Arizona, United States
Products
Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0286-2027Want us to check the next one for you?
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