The Recall Desk
LowFDA (Devices)·Z-1041-2026·Announced 2026-01-21

CT pendant upgrades recalled for missing a safe hand position label

Mobius Imaging is recalling 26 detachable 10in pendant upgrade components for the AIRO CT X-ray System because they do not carry the Safe Hand Position Warning label.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: Scored 1 under the documentation criterion: the record cites a missing warning label with no product defect or reported harm.

Plain-English summary

The Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography X-ray System is being recalled by Mobius Imaging, LLC.

The reason given in the enforcement record is that AIRO pendant replacement kits and upgrades do not possess the "Safe Hand Position Warning" label.

The record lists 26 units, part number MI-70-0128, UDI (01) 00869346000200, with serial numbers listed in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.

The record describes a missing warning label rather than a defect in the component, and states no injuries. Facilities should follow the firm's instructions.

The recalled product

Product
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Manufacturer
Mobius Imaging, LLC
Category
Medical Device — CT scanner
Hazard
Affected units
26

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)

  • Part No. MI-70-0128
  • UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX
  • Serial No. 2232206183
  • 2232206193
  • 2232206203
  • 2232206213
  • 2232206223
  • 2232206233
  • 2235522143
  • 2235522153
  • 2235522163
  • 2236339153
  • 2236339163
  • 2236339173
  • 2236339183
  • 2303429483
  • 2303429503
  • 2313925663
  • 2313925673
  • 2316030773

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Mobius Imaging, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Mobius Imaging, LLC

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Same hazard · missing label

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