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Recall Observatory FDA recall evidence

Device product

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

Z-0957-2023

December 07, 2022

Class II

Product summary

Firm
Mobius Imaging, LLC
Event
Event 91258
Status
Ongoing
Classification
Class II
Quantity
303
Official record key
device-enforcement:Z-0957-2023

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.