Recall MonitorHealth Products
Azurion Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Azurion Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Azurion 7 M12 | Not applicable. | 722233 |
| Azurion 7 M12 | Not applicable. | 722 223 |
| Azurion 7 M12 | Not applicable. | 722078 |
| Azurion 7 B12 | Not applicable. | 722067 |
| Azurion 7 B12 | Not applicable. | 722235 |
| Azurion 5 M20 | Not applicable. | 722232 |
| Azurion 7 M20 | Not applicable. | 722 224 |
| Azurion 7 M20 | Not applicable. | 722079 |
| Azurion 7 M20 | Not applicable. | 722234 |
| Azurion 7 B20 | Not applicable. | 722068 |
| Azurion 7 B20 | Not applicable. | 722 226 |
| Azurion 7 B20 | Not applicable. | 722236 |
Issue
Philips has identified two software-related issues affecting Azurion R2.x.10, R3.0, R3.1 and R4.0 systems that may result in delay of therapy, procedural complications and/or inappropriate treatment.Issue 1: Image quality degradationIssue 2: Loss of geometry movements - Applicable to systems with an AD7X table only