FDA Device recall Z-0957-2023
MobiCT-32 AIRO Mobile CT Scanner, Cat
- FDA Device
- Class II
- ongoing
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class II recall of MobiCT-32 AIRO Mobile CT Scanner, Cat by Mobius Imaging, citing stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0957-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-07 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mobius Imaging |
| Distribution | US |
Product
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Reason
Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider when transporting the unit in reverse by providing labels to be affixed onto the AIRO.
Identifiers
| code_info | UDI-DI: 00869346000200 ALL Serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0957-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.