Mobius Imaging, LLC: Medical Device Recall in 2023 - (Recall #: Z-0957-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 7, 2022

Date Posted: January 25, 2023

Recall Number: Z-0957-2023

Event ID: 91258

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.

Status: Ongoing

Product Quantity: 303

Code Information:

UDI-DI: 00869346000200 ALL Serial numbers

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.

Voluntary or Mandated:

Voluntary: Firm initiated