Philips Multidiagnost Eleva, Allura Xper and Azurion systems
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Allura Xper Fd20 Or Table (Product Of Alluraclarity Family) | Contact the manufacturer. | 722035 |
| Allura Xper Fd10/10 (Product Of Alluraclarity Family) | Contact the manufacturer. | 722027 |
| Allura Xper Fd20/20 (Product Of Alluraclarity Family) | Contact the manufacturer. | 722038 |
| Azurion 7 M12 | Contact the manufacturer. | 722 223 722 078 |
| Azurion 7 M20 | Contact the manufacturer. | 722 224 722 079 |
| Azurion 7 B20 | Contact the manufacturer. | 722 226 722 068 |
| Multidiagnost Eleva - Image Intensifier - Tv Image Detector | Contact the manufacturer. | 0708MD02 |
| Allura Xper Fd10 | Contact the manufacturer. | ALLURA XPER FD10 001443 |
| Multidiagnost Eleva - Flat Detector - Image Detector | Contact the manufacturer. | 0708MD02 |
| Allura Xper Fd10 (Product Of Alluraclarity Family) | Contact the manufacturer. | 722026 |
| Allura Xper Fd20 (Product Of Alluraclarity Family) | Contact the manufacturer. | 722028 |
| Azurion 7 B12 | Contact the manufacturer. | 722 067 |
| Allura Xper Fd20/10 (Product Of Alluraclarity Family) | Contact the manufacturer. | 722029 |
Issue
Philips has become aware of a potential safety issue with the wired and wireless foot switch used with the Philips Multidiagnost Eleva, Allura Xper and Azurion systems, where there is a possibility of unintended radiation. The wired and wireless foot switch are used to control fluoroscopy, exposure and other functions, such as single shot, light control and toggle between x‐ray planes (for bi‐plane systems). A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation, because of:
• Build‐up of dense or sticky fluids on the foot switch (e.g., blood or contrast fluid), if not properly cleaned.
• Use of protective covers that are either the wrong size or incorrectly placed on the foot switch.
• Dislodgement of a screw holding the handle of the foot switch, subsequently becoming lodged within the foot switch housing.
• An additional screw inadvertently left inside the foot switch housing during manufacturing.
Philips has not received any reports of harm resulting from sticking foot switches.
Recall Start Date: August 9, 2023
Additional information
Details
Philips Medical Systems Nederland B.V.
Veenpluis 6, Best, Netherlands, 5684 PC
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