Public recall detail

Airo Mobile CT System

2024-02-16

medium
Recall Safety notice
Quick summary

Quick summary: Airo Mobile CT System. Date: 2024-02-16.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Airo Mobile CT System. Date: 2024-02-16.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandMobius Imaging, Llc
ProductAiro Mobile CT System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75081

Affected products

ProductAiro Mobile CT System
LotAll lots.
ModelMOBICT-32
Serial numberAll lots.
DescriptionAiro Mobile CT System

Issue

As part of continuous improvement efforts the Airo software was reviewed as per Stryker procedure. During review Stryker has identified software bugs that may impact device performance and user experience. These software issues are present on previous software release versions (1.3.0-2.1.1). Recall start date: February 8, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesMobius Imaging, Llc 2 Shaker Road, Shirley, Massachusetts, United States, 01464
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75081
Background{}
CompaniesMobius Imaging, Llc 2 Shaker Road, Shirley, Massachusetts, United States, 01464
AudiencesHealthcare
Source updated2024-02-16

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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