FDA recall Z-0957-2023

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2022-12-07

Report date

2023-01-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Shirley, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0957-2023