Reported Jan 25, 2023 · Ongoing

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

Mobius Imaging, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mobius Imaging, LLC · 2 Shaker Rd Ste F100 · Shirley, MA · 01464-2535

Is this the product you have?

    • MobiCT-32 AIRO Mobile CT Scanner
    • Cat. No. MobiCT-32
    • mobile computed tomography system
Lot codes and dates
  • UDI-DI00869346000200 ALL Serial numbers
Amount recalled
303

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:44 PM UTC

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