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

Recall Z-0344-2023 — MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1

U.S. FDA — Device Enforcement · United States · 2022-11-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0344-2023
Date of alert
2022-11-18
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 a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.