Public recall detail

Azurion 7 M20

2024-01-04

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Recall Safety notice
Quick summary

Quick summary: Azurion 7 M20. Date: 2024-01-04.

Recommended action

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

Recall details

Quick summary: Azurion 7 M20. Date: 2024-01-04.

Official details

Affected product details

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

BrandPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ProductAzurion 7 M20
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74843

Affected products

ProductAzurion 7 M20
LotAll lots.
Model722 224
Serial numberAll lots.
DescriptionAzurion 7 M20

Issue

Philips has become aware of a potential safety issue with the Azurion 7 M20 Flexarm System ("flexarm") with a Maquet Magnus Table with software versions 05.02.12 and 05.02.15 ("table"). Due to a communication issue between the flexarm and the table, motorized movements of the table and/or the flexarm may be lost. A representative of Getinge (manufacturer of the Maquet Magnus Table) will arrange a site visit to return the software of your table to version 05.02.12. After this change, your system will be subject to the medical device recall letter (HS23039R/2023-IGT-BST-020). Recall start date: December 13, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74843
Background{}
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
AudiencesHealthcare
Source updated2024-01-04

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

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