Public recall detail

O-Arm 1000 Imaging System - Base O-Arm

2023-08-04

medium
Recall Safety notice
Quick summary

Quick summary: O-Arm 1000 Imaging System - Base O-Arm. Date: 2023-08-04.

Recommended action

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

Recall details

Quick summary: O-Arm 1000 Imaging System - Base O-Arm. Date: 2023-08-04.

Official details

Affected product details

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

BrandMedtronic Navigation, Inc. [Littleton]
ProductO-Arm 1000 Imaging System - Base O-Arm
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-74066

Affected products

ProductO-Arm 1000 Imaging System - Base O-Arm
LotC2968 C3363
ModelBI-700-00027120
Serial numberC2968 C3363
DescriptionO-Arm 1000 Imaging System - Base O-Arm

Issue

Medtronic identified O-Arm O2 imaging systems where an internal ground cable may be installed backward. When the cable is installed inverted, a portion of the uninsulated cable is not covered by the zippered jacket. Recall start date: July 25, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesMedtronic Navigation, Inc. (Littleton) 300 Foster Street, Littleton, Massachusetts, United States, 01460
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74066
Background{}
CompaniesMedtronic Navigation, Inc. (Littleton) 300 Foster Street, Littleton, Massachusetts, United States, 01460
AudiencesHealthcare
Source updated2023-08-04

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

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