Z-1140-2019Class II

Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product...

Name: Z-1140-2019 Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product...
Creator: Philips Medical Systems Nederlands
Published: 2019-02-19
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2019-02-19 / Terminated / root cause: design

FDA source

Philips Medical Systems Nederlands began a recall of 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... on 2019-02-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1140-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-19
Posted: 2019-04-13
Terminated: 2020-10-14
Recalling firm: Philips Medical Systems Nederland B.V.
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.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: 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 tag: design
FDA 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 in commerce: 7209 total
Distribution: US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1140-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1140-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-13
Z-1141-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-13

Product code IZI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)