Azurion Systems
Brand(s)
Last updated
Summary
Product
Azurion Systems
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 |
|---|---|---|
| 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 degradation
Issue 2: Loss of geometry movements - Applicable to systems with an AD7X table only
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
Recall date
Identification number
RA-82414
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