Philips Medical Systems Recalls Foot Switches for Imaging Systems
Philips Medical Systems is recalling 7,209 foot switches used with specific imaging systems because bent pedals may prevent 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 involves a functional defect (inability to make images) rather than a direct risk of serious 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 Philips MultiDiagnost Eleva with Flat Detector and Allura Xper FD Series imaging systems. The recall covers specific product codes and foot switch models, including wired and wireless variants.
The recall is being conducted because foot switches frequently used on non-flat surfaces or in pedestals may develop bent pedals. This defect can cause an intermittent or continuous inability to make live fluoroscopy images or exposures. This action is an expansion of a previous recall, Z-1280-2016.
The affected units were distributed nationwide in California, Florida, Michigan, Oregon, Pennsylvania, Texas, and Washington. Users of these devices should stop using the affected foot switches and contact Philips Medical Systems for further instructions.
The recalled product
- Product
- Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, i
- Manufacturer
- Philips Medical Systems Nederlands
- Hazard
- 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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