FDA-Device2022-12-07Class II
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Mobius Imaging, LLC
Hazard
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.
Sold states
Domestic distribution to consignees in Colorado, Tennessee, and Utah.
Affected count
3
Manufactured in
2 Shaker Rd Ste F100, Shirley, MA, United States
Products
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0344-2023Don't want to check this manually?
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