Recall Z-1280-2016 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems, Inc.
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 Xper FD1O/10, 722012 Allura Xper FD2O, 722013 Allura XPER FD2O BIPLANE, 722014 Allura Xper FD1O OR Table, 722015 Allura Xp
| Date | Sep 24, 2014 |
| Status | Terminated |
| Reason | Loss of key image functionality due to a bent pedal of the Footswitch. |
| Root cause | Device Design |
| Action | Field Safety Noticed was mailed on September 24, 2014 via Certified Return Receipt. This FCC consists of a Mechanical Hardware update of the Footswitch in order to prevent bent pedals and therefore prevents an intermittent or continuous inability of making live fluoro images or exposures. Customers with questions were instructed to contact their local Philips representative. |
| Quantity | 4180 devices |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to: CZECH REPUBLIC ALBANIA ALGERIA ARGENTINA AUSTRALIA AUSTRIA AZARBAIJAN BAHAMAS BANGLADESH BELGIUM BRAZIL BULGARIA CAYMAN ISLANDS CHILE CHINA COLUMBIA COSTA RICA CROATIA CUBA CZECHOSLOVAKIA DENMARK DOMINICAN REPUB ECUADOR EGYPT ESTONIA F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031333 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 Philips Medical Systems North America, Inc., May 13, 2003 |
| K033737 | ALLURA XPER FD20 Philips Medical Systems North America, Inc., Dec 9, 2003 |
| K041949 | ALLURA XPER FD10 Philips Medical Systems North America Co., Jul 30, 2004 |
| K050151 | MULTIDIAGNOST ELEVA Philips Medical Systems North America, Inc., Feb 9, 2005 |
| K984545 | RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS Philips Medical Systems North America, Inc., Feb 25, 1999 |