Recall Z-0957-2023— Mobius Imaging, LLC

Name: FDA recall Z-0957-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-07

Class II · Ongoing

Class II FDA medical device recall by Mobius Imaging, LLC, initiated 2022-12-07. It names one FDA 510(k) clearance: K180393. Product: MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.. 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..

Recalling firm: Mobius Imaging, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-12-07
Firm location: Shirley, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K180393 — AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC·cleared 2018-03-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.