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U.S. Department of Health and Human Services

Class 2 Device Recall Orthoscan VERSA Accessory Cart and Versa Mini CArm System

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 Class 2 Device Recall Orthoscan VERSA Accessory Cart and Versa Mini CArm Systemsee related information
Date Initiated by FirmSeptember 03, 2026
Date PostedOctober 23, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0286-2027
Recall Event ID 99979
510(K)NumberK243452 
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
ProductOrthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
Code Information 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
FEI Number 3017541298
Recalling Firm/
Manufacturer		 ZIEHM-ORTHOSCAN INC
14555 N 82nd St
Scottsdale AZ 85260-2525
For Additional Information ContactKevin Bridgman
480-5038010
Manufacturer 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 Determined
Cause 2		Process control
ActionOn 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 Commerce55 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OXO
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