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
- missing-label
- warning-label
- ct-pendant
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.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22