Home / Recalls / Philips Medical Systems Nederlands / Z-1140-2019

Z-1140-2019 Class II Terminated

Recalled by Philips Medical Systems Nederlands — Best, N/A

Recall Details

Product Type
Devices
Report Date
April 24, 2019
Initiation Date
February 19, 2019
Termination Date
October 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7209 total

Product Description

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.

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.

Distribution Pattern

US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.

Code Information

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.

Other recalls by Philips Medical Systems Nederlands

  • Z-1240-2019 Class II — Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energizatio (March 25, 2019)
  • Z-1141-2019 Class II — Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 72 (February 19, 2019)
  • Z-0920-2019 Class II — Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging Sy (December 21, 2018)
  • Z-0902-2019 Class II — Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging (December 21, 2018)
  • Z-0924-2019 Class II — MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System (December 21, 2018)
  • Z-0918-2019 Class II — Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System (December 21, 2018)
  • Z-0893-2019 Class II — Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System (December 21, 2018)
  • Z-0887-2019 Class II — Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Im (December 21, 2018)
  • Z-0870-2019 Class II — Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System (December 21, 2018)
  • Z-0927-2019 Class II — Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging (December 21, 2018)