Recall MonitorAzurion 7 Systems
· Published by Health Canada · Official notice
Details
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Azurion 7 B12 | 128 | 722 067 |
| Azurion 7 B12 | 151 | 722 067 |
| Azurion 7 M12 | 119 | 722 223 |
| Azurion 7 M12 | 205 | 722 078 |
| Azurion 7 M12 | 444 | 722 078 |
| Azurion 7 M12 | 218 | 722 078 |
| Azurion 7 M12 | 206 | 722 078 |
| Azurion 7 M12 | 204 | 722 078 |
| Azurion 7 M20 | 3459 | 722 224 |
| Azurion 7 M20 | 874 | 722 224 |
| Azurion 7 M20 | 2667 | 722 224 |
| Azurion 7 M20 | 495 | 722 224 |
| Azurion 7 M20 | 1156 | 722 224 |
| Azurion 7 M20 | 3596 | 722 224 |
| Azurion 7 M20 | 875 | 722 224 |
| Azurion 7 M20 | 284 | 722 079 |
| Azurion 7 M20 | 333 | 722 079 |
| Azurion 7 M20 | 1374 | 722 079 |
| Azurion 7 M20 | 783 | 722 079 |
| Azurion 7 M20 | 750 | 722 079 |
| Azurion 7 M20 | 679 | 722 079 |
| Azurion 7 M20 | 352 | 722 079 |
Issue
Philips Azurion systems use solid-state drives (SSDs) in various PCs to store the operating system and image data and to support system functionality. Philips has identified that, during certain repair or service actions, SSDs that are not specified in the medical device file may have been installed. These SSDs may have different performance characteristics, which may include reduced reliability over time. When an SSD does not perform as intended, the symptoms depend on the PC in which the SSD is installed and the function being used. this may result in loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.