The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1280-2016·Announced 2016-04-06

Philips Medical Systems Recalls Foot Switches for Bent Pedal Defect

Philips Medical Systems is recalling 4,180 foot switches used with Allura Xper systems because a bent pedal can cause loss of key image functionality.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, and the hazard is a loss of functionality rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity rating.

Plain-English summary

Philips Medical Systems, Inc. is recalling 4,180 foot switches used with various Philips Allura Xper imaging systems. The recall is due to a defect where the pedal of the footswitch may become bent, which can result in the loss of key image functionality.

The affected devices were distributed nationwide in the United States and internationally to numerous countries. The specific footswitch models involved include various wired and wireless configurations, such as the Footswitch CV 3p 4m, Footswitch MD 3p 6m, and Wireless Footswitch 4p+2.

Healthcare facilities and users of these devices should stop using the affected foot switches and contact Philips Medical Systems for further instructions on repair or replacement.

The recalled product

Product
Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura…
Manufacturer
Philips Medical Systems, Inc.
Category
Medical Device — Imaging Accessories
Hazard
Affected units
4,180

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

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Philips Medical Systems, Inc. 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.

See all 2 products in this recall →

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