Philips Allura and Azurion
Summary
Contact the manufacturer if you require additional information.
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 |
Azurion 7 M20 |
All lots. |
722 224 |
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
| Philips Medical Systems Nederland B.V. |
| Veenpluis 6, Best, Netherlands, 5684 PC |
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