FDA Medical Device Recalls (openFDA)
Mobius Imaging, LLC: MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
- Recall number
- Z-0344-2023
- Recalling firm
- Mobius Imaging, LLC
- Product
- MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
- Status
- Terminated
- Initiated
- 2022-11-18
- Posted
- 2022-12-06
- Terminated
- 2025-02-26
- 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.
- 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 shirleytechnicalsupport@stryker.com or call Stryker Technical Support at 978 386 9619.
- Quantity
- 3
- Distribution
- Domestic distribution to consignees in Colorado, Tennessee, and Utah.
- Lot, serial or model codes
- UDI-DI 00869346000200 Serial Numbers AIRO-0124, AIRO-0145, AIRO-0288
- 510(k) numbers
- ["K180393"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3010151377
- Firm city
- Shirley
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28