Z-0344-2023Class II

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

Name: Z-0344-2023 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software...
Creator: Mobius Imaging, LLC
Published: 2022-11-18
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2022-11-18 / Terminated

FDA source

Mobius Imaging, LLC began a recall of MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1 on 2022-11-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0344-2023
Classification: Class II
Status: Terminated
Initiated: 2022-11-18
Posted: 2022-12-06
Terminated: 2025-02-26
Recalling firm: Brainlab, Inc.
Product: MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Product code: JAK System, X-Ray, Tomography, Computed
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.
FDA root cause: Other
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.
Quantity in commerce: 3
Distribution: Domestic distribution to consignees in Colorado, Tennessee, and Utah.
Product codes and lots: UDI-DI 00869346000200 Serial Numbers AIRO-0124, AIRO-0145, AIRO-0288

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0344-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0344-2023	Class II	Terminated	Voluntary: Firm initiated	2022-12-07	2022-11-30

Product code JAK

K180393Class IIAIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC / cleared 2018-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)