Philips Medical Systems Recalls Foot Switches for Allura Xper Systems
Philips Medical Systems is recalling 7,209 foot switches used with Allura Xper systems because pedals may bend, causing an inability to make live fluoroscopy images or exposures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a functional defect (inability to make images) rather than a direct risk of physical injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems Nederlands is recalling 7,209 foot switches used with various Allura Xper and INTEGRIS systems. This action is an update to a previous recall (Z-1280-2016) to include additional identified units. The affected foot switches are used in vascular, cardiovascular, and neurovascular imaging applications.
The recall is due to a defect where footswitch pedals may get bent if the device is frequently used on a non-flat surface or in the pedestal. This physical deformation can cause an intermittent or continuous inability to make live fluoroscopy images or exposures.
The affected units were distributed nationwide in the United States, specifically in California, Florida, Michigan, Oregon, Pennsylvania, Texas, and Washington. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012 All
- Manufacturer
- Philips Medical Systems Nederlands
- Affected units
- 7,209
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Foot Switches: 452270000141 Footswitch CV 3p 4m
- 452270000151 Footswitch MD 3p 6m
- 452270000142 Footswitch CV 3p 4m
- 452270000381 Footswitch CV 3p 8m
- 452270000382 Footswitch CV 3p 8m
- 459800076001 Footswitch CV 4p+2 4m
- 459800076021 Footswitch CV 4p+2 8m
- 459800415571 Wireless Footswitch 4p+2
- 459800415581 Wireless footswitch set 4p+2
- 459800415531 Wireless Footswitch 3P
- 459800415561 Wireless footswitch set 3P.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Medical Systems Nederlands under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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