MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
FDA device recall Z-0344-2023 · posted 2022-12-06 · Terminated
Recall details
- Recalling firm
- Mobius Imaging, LLC
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 3
- Distribution
- Domestic distribution to consignees in Colorado, Tennessee, and Utah.
- Date initiated
- 2022-11-18
- Date posted
- 2022-12-06
- Date terminated
- 2025-02-26
- Location
- Shirley, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AIRO Computed Tomography (CT) X-ray System (K180393) | Mobius Imaging, LLC | 2018-03-15 |