FDA Medical Device Recalls (openFDA)
Philips Medical Systems Nederlands: 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, interventional and minimally invasive procedures.
- Recall number
- Z-1140-2019
- Recalling firm
- Philips Medical Systems Nederlands
- 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, interventional and minimally invasive procedures.
- Status
- Terminated
- Initiated
- 2019-02-19
- Posted
- not on file
- Terminated
- 2020-10-14
- Reason
- Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.
- Root cause
- Component design/selection
- Action
- The firm previously notified customers on September 24, 2014 as part of Recall Z-1280-2016. On February 21, 2019, the firm sent an updated recall letter to newly identified affected consignees. Customers were alerted that bent pedal of footswitch might cause interruption of live Flouroscopy imaging or exposure. Action to be taken by Customer/User: 1. Before starting a procedure, the user should check the footswitch for possible bent pedals. If bent pedals are found the procedure should not continue and Local Service should be contacted. 2. Do not use the footswitch on an anti-fatigue mat or in the pedestal. 3. Please ensure that all staff with access to the affected systems are informed of the content of this Medical Device Correction. 4. Include this Medical Device Correction together with the documentation of the system until the system has been corrected by Philips. The firm stated that the problem will be resolved by an update of the mechanical hardware of the footswitch which will prevent the pedals of the footswitch from becoming bent. The mechanical hardware was available as of February 2019. Customers will be notified by their local Philips representative to schedule a date for installation of the mechanical hardware update. Technical Support Line: 1-800-722-9377
- Quantity
- 7209 total
- Distribution
- US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K031333","K033737","K041949","K050151","K984545"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 3002807880
- Firm city
- Best
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28