Z-0286-2027

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

Name: Z-0286-2027 Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
Creator: Ziehm-Orthoscan Inc
Published: 2026-09-03
License: https://open.fda.gov/license/

Ziehm-Orthoscan Inc / initiated 2026-09-03 / Open, Classified

FDA source

Recall record

Recall number: Z-0286-2027
Status: Open, Classified
Initiated: 2026-09-03
Posted: 2026-10-23
Recalling firm: Ziehm-Orthoscan Inc
Product: Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
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.
FDA root cause: Process control
Action: On September 11, 2026, Ziehm-Orthoscan issued a Urgent: Medical Device Recall Notification via Email. Ziehm-Orthoscan ask consignees to take the following actions: 1. The device may continue to be used until the corrective action has been completed, provided the user follows the precautions described in this notification and no signs of instability or unintended movement are observed. 2. Users should exercise caution when positioning, moving, or operating the system and monitor assembly, avoid fully extending the display arm until the corrective action has been performed. 3. If unintended movement, instability, loosening, or any other condition related to the issue described in this notification is observed, discontinue use of the affected system and contact Ziehm- Orthoscan immediately for further instructions. 4. Please ensure that a copy of this notification is made available to all users and operators of the affected device. It is recommended that this notification be posted in a visible location near the device until the corrective action has been completed. 5. If the affected device has been transferred, sold, or relocated to another facility or department, please ensure that a copy of this notification is provided to the current user or owner of the device. 6. Please maintain awareness of this notification until the corrective action has been completed and verified by Ziehm-Orthoscan or its authorized representative.
Quantity in commerce: 55 units
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.
Product codes and lots: 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

Product code OXO

K243452Class IIOrthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc. / cleared 2025-01-14

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-21, the FDA export date for this dataset. Page last changed 2026-10-30. View this recall on fda.gov (opens on fda.gov)