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Recall Observatory FDA recall evidence

Device product

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

Z-0344-2023

November 18, 2022

Class II

Product summary

Firm
Mobius Imaging, LLC
Event
Event 91178
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0344-2023

Official wording

Reason: 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.

Code information: UDI-DI 00869346000200 Serial Numbers AIRO-0124, AIRO-0145, AIRO-0288

Distribution pattern: Domestic distribution to consignees in Colorado, Tennessee, and Utah.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.