AIRO Mobile CT System (2021-05-17)
- Starting date:
- May 17, 2021
- Posting date:
- June 3, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75731
Last updated:
2021-06-03
Affected Products
AIRO Mobile CT System
Reason
Stryker has identified software bugs which may impact device performance and user experience. These issues were identified around December 2020. These software issues are present on previous software release versions (1.1.X.X-2.1.0) and will be addressed in the software version 2.1.1 release. Customers may refer to MI-42-001 Airo Truct System user manual, MI-42-0014 software release notes, and MI-42-0005 application guide protocols and principles for additional information regarding this software update.
Affected products
AIRO Mobile CT System
Lot or serial number
Software version 1.1.X.X-2.1.0
Model or catalog number
MOBICT-32
Companies
- Manufacturer
-
MOBIUS IMAGING, LLC
2 SHAKER ROAD
Shirley
01464
Massachusetts
UNITED STATES