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

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  Reason
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  Affected products

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