Public recall detail

Philips Azurion System

2023-03-31

medium
Recall Safety notice
Quick summary

Quick summary: Philips Azurion System. Date: 2023-03-31.

Recommended action

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

Recall details

Quick summary: Philips Azurion System. Date: 2023-03-31.

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.
ProductPhilips Azurion System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73421

Affected products

ProductAzurion 7 B12
Lot151 188
Model722 067
Serial number151 188
DescriptionAzurion 7 B12
ProductAzurion 7 B20
Lot149 296
Model722 226 722 068
Serial number149 296
DescriptionAzurion 7 B20
ProductAzurion 7 M20
LotMore than 10 numbers, contact manufacturer.
Model722 224 722 079
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAzurion 7 M20
ProductAzurion 7 M12
LotMore than 10 numbers, contact manufacturer.
Model722 223 722 078
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAzurion 7 M12

Issue

Philips Azurion System may unexpectedly lose X-ray functionality. Due to a software issue, a mechanism that is present in the system to manage the number and size of log trace files does not function properly. Without this mechanism, the log trace files created by the system (e.g., at start, during use) may occupy the full disk capacity of the Philips Azurion system. When the full disk capacity is reached, X-ray functionality will cease to be available without an advance warning to the user. Recall start date: March 23, 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-73421
Background{}
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
AudiencesHealthcare
Source updated2023-03-31

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

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