Recall Ledger

Orthoscan VERSA Accessory Cart recall (ZIEHM-ORTHOSCAN INC)

Medical deviceClass IIOngoing

Summary: ZIEHM-ORTHOSCAN INC is recalling 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.

What is being recalled

Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was 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. (states named: 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)

How to tell if yours is 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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-0286-2027
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedSeptember 3, 2026
ReportedNovember 4, 2026
CompanyZIEHM-ORTHOSCAN INC
Company locationScottsdale, AZ, United States
Initiated byVoluntary: Firm initiated
Quantity55 units

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