Recall Z-1120-2015 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems, Inc.
Philips Medical System Allura Xper X-Ray Angiographic
| Date | Mar 2, 2015 (initiated Jun 6, 2014) |
| Status | Terminated |
| Reason | In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips Medical Planned Action: 1. The affected customers will be sent a customer notification letter that identifies the software corrective actions and indicates that these corrective actions will be provided to the end-user free of charge 2. A mandatory Field Change Order with reference FCO72200270 will be released that requires Philips field service engineers to install Software release R7.2.8 which addresses the buzzer issue. The expected date of this FCO will be February 2015. The software release will contain updated timer function code to correct the intermittent fluoroscopy timer m |
| Quantity | 7439 |
| Distribution | Worldwide Distribution - USA nationwide including Puerto Rico, Austria, Azerbaijan, Australia, Algeria, Argentina, Albania, Brazil, Belgium, Bangladesh, Bahamas, Bulgaria, Cambodia, Chile, Canada, China, Croatia, Czech Republic, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102005 | ALLURA XPER OR TABLE SERIES Philips Medical Systems North America, Inc., Aug 9, 2010 |