[pending] Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Pending LLM rewrite. Source: FDA_DEVICE Z-1040-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
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 — Devices
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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