Home / Recalls / Mobius Imaging, LLC / Z-0344-2023

Z-0344-2023 Class II Terminated

Recalled by Mobius Imaging, LLC — Shirley, MA

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

Other recalls by Mobius Imaging, LLC

  • Z-1040-2026 Class II — Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) (December 4, 2025)
  • Z-1041-2026 Class II — Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) (December 4, 2025)
  • Z-0957-2023 Class II — MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (December 7, 2022)
  • Z-2991-2018 Class II — AIRO Mobile CT System Model # MobiCT-32 (August 1, 2018)
  • Z-0715-2018 Class II — AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is i (September 26, 2017)
  • Z-1016-2015 Class II — Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x (December 8, 2014)