Z-0957-2023Class II

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

Name: Z-0957-2023 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system
Creator: Mobius Imaging, LLC
Published: 2022-12-07
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2022-12-07 / Open, Classified / root cause: labeling and UDI

FDA source

Mobius Imaging, LLC began a recall of MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system on 2022-12-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0957-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-07
Posted: 2023-01-17
Recalling firm: Brainlab, Inc.
Product: MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Use error
Action: On December 7, 2022, the firm notified customers via Urgent Medical Device Correction letters. Customers were informed that the firm would add additional warning labels to the Airo to increase visibility of instructions for users to consider when transporting an Airo TruCT unit in reverse. A service representative will contact your facility once labels are available (anticipated February 2023) to schedule a time to affix the labeling to your Airo TruCT unit. In the interim, please ensure all Airo TruCT users and other relevant personnel in your facilities are informed of this issue. If the devices have been distributed to other organizations, inform Stryker so that they may inform personnel at the new locations appropriately. If you have any questions or concerns regarding this notification, please contact [email protected] or call Stryker Technical Support at 978 386 9619.
Quantity in commerce: 303
Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Chinese Taipei, Denmark, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Pakistan, Poland, Russian Federation, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
Product codes and lots: UDI-DI: 00869346000200 ALL Serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0957-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0957-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-17

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)