Public recall detail

Philips Lung Suite Bundles

2024-06-17

medium
Recall Safety notice
Quick summary

Quick summary: Philips Lung Suite Bundles. Date: 2024-06-17.

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 Lung Suite Bundles. Date: 2024-06-17.

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 Lung Suite Bundles
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-75682

Affected products

ProductAllura XPER FD20 OR Table (Product Of AlluraClarity Family)
LotNot applicable.
Model722035
Serial numberNot applicable.
DescriptionAllura XPER FD20 OR Table (Product Of AlluraClarity Family)
ProductEmboGuide
LotNot applicable.
Model001012
Serial numberNot applicable.
DescriptionEmboGuide
Product3D Roadmap
LotNot applicable.
Model001003
Serial numberNot applicable.
Description3D Roadmap
ProductAzurion 7 M20
LotNot applicable.
Model722 224 722 079
Serial numberNot applicable.
DescriptionAzurion 7 M20
ProductXperGuide
LotNot applicable.
Model001006
Serial numberNot applicable.
DescriptionXperGuide
ProductSmartCT 1.0
LotNot applicable.
Model001018
Serial numberNot applicable.
DescriptionSmartCT 1.0
Product3D-RA
LotNot applicable.
Model001102
Serial numberNot applicable.
Description3D-RA

Issue

The lung suite bundles, i.e., lung advanced, lung premium, have been promoted for use for bronchoscopy procedures, while some of the individual medical devices in the relevant bundles are not approved for use for bronchoscopy procedures, but advertised as such. Recall start date: May 29, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology Health products - Medical devices - General hospital and personal use
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-75682
Background{}
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
AudiencesHealthcare
Source updated2024-06-17

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

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