CLASS II ONGOING Device recall · Reported 4 Nov 2026 · FDA Enforcement Report
Orthoscan Versa Accessory Cart recalled by Ziehm-orthoscan
Ziehm-orthoscan is recalling Orthoscan Versa Accessory Cart, distributed nationwide in the US. The recall was initiated on 3 Sep 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0286-2027
- FDA event ID
- 99979
- Recalling firm
- Ziehm-orthoscan, Scottsdale, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Sep 2026
- FDA classified
- 23 Oct 2026
- Reported
- 4 Nov 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 3 Sep 2026 | Recall initiated by company | |
| 23 Oct 2026 | Classified by FDA | +50 days |
| 4 Nov 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKansasMassachusettsMarylandMichiganMinnesotaNorth CarolinaNebraskaNevadaNew YorkOhioOregonSouth Carolina
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/ Mini C-Arm serial number (6Axxxx)/Accessory cart serial Number: (VCXXX): 1 6A0110 /VC0110 2 6A0111 /VC0111 3 6A0112 /VC0112 4 6A0115 /VC0113 5 6A0114 /VC0114 6 6A0117 /VC0115 7 6A0116 /VC0116 8 6A0113 /VC0117 9 6A0118 /VC0118 10 6A0119/ VC0119, VC0120; 11 6A0120 /VC0121; 12 6A0121 /VC0122; 13 6A0123 /VC0123; 14 6A0122 /VC0124; 15 6A0126 /VC0125; 16 6A0133 /VC0134; 17 6A0124 /VC0126; 18 6A0128 /VC0128; 19 6A0127 /VC0129; 20 6A0129 /VC0130; 21 6A0125 /VC0127; 22 6A0131 /VC0132; 23 6A0134 /VC0133; 24 6A0142 /VC0144; 25 6A0136 /VC0136; 26 6A0132 /VC0137; 27 6A0137 /VC0138; 28 6A0138 /VC0139; 29 6A0139 /VC0140; 30 6A0140 /VC0141; 31 6A0141 /VC0142; 32 6A0146 /VC0147; 33 6A0143 /VC0143; 34 6A0144 /VC0145; 35 6A0152 /VC0153; 36 6A0147 /VC0148; 37 6A0148 /VC0149; 38 6A0149 /VC0150; 39 6A0150 /VC0151; 40 6A0151 / VC0152; 41 6A0163 / VC0165; 42 6A0130 / VC0131; 43 6A0155 / VC0156; 44 6A0157 / VC0157; 45 6A0156/ VC0158; 46 6A0158 / VC0159, VC0160; 47 6A0159/ VC0161; 48 6A0160/ VC0162; 49 6A0161 / VC0163; 50 6A0162 VC0164; 51 6A0153 VC0154; 52 6A0164 VC0166; 53 6A0165 VC0167
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 10 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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