Recall Z-0344-2023— Mobius Imaging, LLC
Class II · Terminated
Class II FDA medical device recall by Mobius Imaging, LLC, initiated 2022-11-18, terminated 2025-02-26. It names one FDA 510(k) clearance: K180393. Product: MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1. 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..
- Recalling firm
- Mobius Imaging, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-11-18
- Terminated
- 2025-02-26
- Firm location
- Shirley, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.