Z-0344-2023 Class II Terminated
FDA device recall Z-0344-2023 was initiated by Mobius Imaging, LLC on November 18, 2022 and is designated Class II. 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 bypas… The recall status is terminated (terminated February 26, 2025). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- December 7, 2022
- Initiation Date
- November 18, 2022
- Termination Date
- February 26, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
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.
Distribution Pattern
Domestic distribution to consignees in Colorado, Tennessee, and Utah.
Code Information
UDI-DI 00869346000200 Serial Numbers AIRO-0124, AIRO-0145, AIRO-0288