Philips Wired Foot Switch
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Allura Xper Fd10 |
Not applicable. |
ALLURA XPER FD10 |
Allura Xper Fd10/10 (Product Of Alluraclarity Family) |
Not applicable. |
722027 |
Azurion7 B12 |
Not applicable. |
722 067 |
Azurion7 B20 |
Not applicable. |
722 226 |
Allura Xper Fd20/10 (Product Of Alluraclarity Family) |
Not applicable. |
722029 |
Allura Xper Fd20 Ortable(Product Of Alluraclarity Family) |
Not applicable. |
722035 |
Allura Xper Fd20/20 (Product Of Alluraclarity Family) |
Not applicable. |
722038 |
Multidiagnost Eleva ‐ Flat Detector ‐Image Detector |
Not applicable. |
0708MD02 |
Azurion7 M12 |
Not applicable. |
722 223 |
Multidiagnost Eleva ‐ Image Intensifier‐Tv Image Detector |
Not applicable. |
0708MD02 |
Allura Xper Fd10(Product Of Alluraclarity Family) |
Not applicable. |
722026 |
Allura Xper Fd20(Product Of Alluraclarity Family) |
Not applicable. |
722028 |
Azurion7 M20 |
Not applicable. |
722 224 |
Issue
Philips has become aware of a potential safety issue with the wired foot switch used with the Philips Allura Xper, Allura Centron, Azurion and Multidiagnost‐Eleva systems, where there is a possibility of loss of imaging functionality resulting from no or intermittent x‐ray radiation initiation. The wired foot switch is used to control fluoroscopy, exposure and other functions like single shot, light control, and
toggle between x‐ray planes (for bi‐plane system), this in combination with the above‐mentioned Philips systems. Evaluation of complaints received identified situations where there is a possibility for no or intermittent x‐ray radiation related to this wired foot switch. If there is no or intermittent x‐ray radiation this will lead to loss of imaging functionality which may result in delayed diagnosis or interruption of procedure.
Recall start date: August 18, 2023
Additional information
Details
| Philips Medical Systems Nederland B.V. |
| Veenpluis 6, Best, Netherlands, 5684 PC |