FDA recall Z-0344-2023

Product

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

Domestic distribution to consignees in Colorado, Tennessee, and Utah.

Key facts

Status

Terminated

Initiation date

2022-11-18

Report date

2022-12-07

Termination date

2025-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Shirley, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0344-2023