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
Get notified
Receive notifications for new and updated recalls and alerts by category.