Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0957-2023 — MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.

U.S. FDA — Device Enforcement · United States · 2022-12-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0957-2023
Date of alert
2022-12-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mobius Imaging, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00869346000200
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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