Device recall
Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
- Recall number
- Z-0286-2027
- Event id
- 99979
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- ZIEHM-ORTHOSCAN INC
- Report date
- Nov 4, 2026
- Posted
- Oct 23, 2026
- Initiated
- Sep 3, 2026
- Center classification date
- Oct 23, 2026
- Product code
- OXO
- Device type
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- 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.
- Root cause
- Process control
- Quantity
- 55 units
- Code info
- 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
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K243452
- Location
- Scottsdale, AZ, United States