MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32… recallZ-0344-2023 · Mobius Imaging, LLC · initiated Nov 18, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mobius Imaging, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0344-2023
- Status
- Terminated
- Initiated by the company
- Nov 18, 2022
- Posted by the FDA
- Dec 6, 2022
- Recalling firm
- Mobius Imaging, LLC
- Quantity
- 3
- Product code
- JAK
- FDA submissions
- K180393
- Distribution
- Domestic distribution to consignees in Colorado, Tennessee, and Utah.
Product description
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Code information (models, lots, serial numbers)
UDI-DI 00869346000200 Serial Numbers AIRO-0124, AIRO-0145, AIRO-0288
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Airo® MobiCT-32Mobius Imaging, LLC · System, X-Ray, Tomography, Computed4 recalls4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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