Philips Allura and Azurion
Last updated
Summary
Product
Philips Allura and Azurion
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Allura Xper Fd10 (Product Of Alluraclarity Family) | All lots. | 722026 |
| Allura Xper Fd20 Or Table (Part Of Alluraclarity Family) | All lots. | 722035 |
| Vitros Chemistry Products System - Eco2 Slides (Carbon Dioxide) | All lots. | 722 227 |
| Integris H5000c Cardiology Imaging System | All lots. | 722016 |
| Azurion 5 M20 | All lots. | 722 228 |
| Allura Xper Fd10 | All lots. | 001443 |
| Allura Xper Fd20/15 | All lots. | 722058 |
| Allura Xper Fd10 Or Table (Product Of Alluraclarity Family) | All lots. | 722033 |
| Allura Xper Fd20 (Product Of Alluraclarity Family) | All lots. | 722028 |
| Allura Xperfd20/20 (Product Of Alluraclarity Family) | All lots. | 722038 |
| Azurion 7 M12 | All lots. | 722 223 722 078 |
| Azurion 7 M20 | All lots. | 722 224 722 079 |
Issue
Philips has identified a potential safety issue with the Philips Allura and Azurion product families having monoplane fixed ceiling mounted systems. The ceiling mounted l-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the l-arm and other hospital equipment (i.e., an operating light) were to occur. Although the cover is retained by a safety chain, if a collision were to occur the chain may also detach resulting in the cover falling on the patient, user, or bystander.
Recall start date: November 3, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
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-74640
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