MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
FDA Recall Z-0344-2023 · Posted 2022-12-06
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Recalling FirmMobius Imaging, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2022-11-18
Date Terminated2025-02-26
Product Quantity3
Reason for Recall
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.
Firm Action
On November 18, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. Customers were informed that a service representative will contact their facility to schedule a time to replace the batteries in the affected devices. The customer does not need to take additional action while waiting for the battery preplacement.
If you have any questions or concerns regarding this update, please contact [email protected] or call Stryker Technical Support at 978 386 9619.
Root Cause
Other
Distribution Pattern
Domestic distribution to consignees in Colorado, Tennessee, and Utah.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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