Home / Recalls / Mobius Imaging, LLC / Z-0957-2023

Z-0957-2023 Class II Ongoing

Recalled by Mobius Imaging, LLC — Shirley, MA

FDA device recall Z-0957-2023 was initiated by Mobius Imaging, LLC on December 7, 2022 and is designated Class II. Reason for recall: Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for use… The recall status is ongoing. Affected quantity: 303.

Recall Details

Product Type: Devices
Report Date: January 25, 2023
Initiation Date: December 7, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 303

Product Description

MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.

Reason for Recall

Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider when transporting the unit in reverse by providing labels to be affixed onto the AIRO.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Chinese Taipei, Denmark, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Pakistan, Poland, Russian Federation, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

Code Information

UDI-DI: 00869346000200 ALL Serial numbers

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-0344-2023 Class II — MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (November 18, 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)