The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0286-2027·Announced 2026-11-04

Ziehm-Orthoscan Recalls 55 Versa Mini C-Arm Systems for Weld Defect

Ziehm-Orthoscan is recalling 55 Orthoscan VERSA Accessory Carts and Versa Mini C-Arm Systems because a weld defect may cause the monitor arm to separate from the cart.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as Class II, and the source describes a weld defect that may cause the monitor arm to separate from the cart. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

Ziehm-Orthoscan Inc. is recalling 55 units of the Orthoscan VERSA Accessory Cart (REF: 1000-0021) and Versa Mini C-Arm System (REF: 1000-0020). The recall was initiated because the accessory cart weldment does not conform to weld dimensional specifications. This defect may result in the separation of the monitor arm mounting structure from the cart.

The affected products were distributed worldwide, including nationwide distribution in the United States across 24 states and in Germany, Australia, Spain, Switzerland, and Japan. The source text does not report any illnesses, injuries, or deaths associated with this defect.

Healthcare facilities and users should identify affected units by checking the serial numbers listed in the recall notice. Users should contact Ziehm-Orthoscan Inc. for instructions on how to address the defect.

The recalled product

Product
Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
Manufacturer
ZIEHM-ORTHOSCAN INC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
55

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

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