Health product recall

Philips Lung Suite Bundles

Last updated

Summary

Product
Philips Lung Suite Bundles
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Allura XPER FD20 OR Table (Product Of AlluraClarity Family) Not applicable. 722035
EmboGuide Not applicable. 001012
3D Roadmap Not applicable. 001003
Azurion 7 M20 Not applicable. 722 224 722 079
XperGuide Not applicable. 001006
SmartCT 1.0 Not applicable. 001018
3D-RA Not applicable. 001102

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Health products - Medical devices - General hospital and personal use
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75682

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