CT pendant replacement kits recalled for missing a safe hand position label
Mobius Imaging is recalling 101 detachable 10in pendant replacement 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 Pend FRU-1 pendant 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 101 units, part number MI-76-0237, 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 Pend FRU-1 Pend 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-76-0237
- UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX
- Serial No. 2232206713
- 2232206723
- 2232206753
- 2232206763
- 2303430363
- 2303430373
- 2303430383
- 2303430393
- 2304034583
- 2304034593
- 2304034603
- 2304034613
- 2304034623
- 2305514123
- 2305514133
- 2305514143
- 2305514153
- 2311019263
Distribution
Distributed nationwide across the United States.
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