The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1279-2016·Announced 2016-04-06

Philips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect

Philips Medical Systems is recalling 168 foot switches used with the MultiDiagnost Eleva system 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. The hazard is a functional defect (loss of image functionality) with no reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips Medical Systems, Inc. is recalling 168 foot switches used with the Philips MultiDiagnost Eleva with Flat Detector. The affected product codes are 708037 and 708038. These foot switches are intended for use with a multifunctional system capable of performing general radiography, fluoroscopy, and angiography.

The recall is due to a bent pedal on the foot switch, which can result in the loss of key image functionality. The source text does not report any injuries, illnesses, or deaths associated with this defect.

The affected units were distributed nationwide in the United States and internationally to numerous countries. Consumers and healthcare facilities 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 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with…
Manufacturer
Philips Medical Systems, Inc.
Category
Medical Device — Radiology Equipment
Hazard
Affected units
168

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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