FDA DevicesClass II
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) ...
Published: January 21, 2026Recall ID: Z-1041-2026Category: devicesCountry: US
Reason for Recall / Hazard
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Product Description & Identification
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Additional Source Details
| Field | Value |
|---|---|
| City | Shirley |
| State | MA |
| Event id | 98099 |
| Address 1 | 2 Shaker Rd Ste F100 |
| Code info | 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, 2316030783, 2316703503, 2316703523, 2317415473, 2320006923, 2320006933, 2323513413, 70-0128-13904392. |
| Postal code | 01464-2535 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 26 units |
| Reason for recall | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251204 |
| Initial firm notification | Letter |
| Center classification date | 20260109 |
Overview
- Recalling FirmMobius Imaging, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI.