Recall Z-1140-2019 ยท IZI System, X-Ray, Angiographic
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.
| Date | Feb 19, 2019 |
| Status | Terminated |
| 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 |
| Quantity | 7209 total |
| Distribution | US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA. |
| 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 |