Recall Z-0727-2016 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diag
| Date | Jan 30, 2016 (initiated Nov 3, 2015) |
| Status | Terminated |
| Reason | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. |
| Root cause | Device Design |
| Action | The firm, Philips, issued "URGENT-Field Safety Notices" dated 10/26/2015 and 11/19/2015 to its customers. The notices described the product, problem and actions to be taken. The customers were instructed to ensure the audible signal (X-ray buzzer) is always enabled, to activate only ONE fluoroscopy pedal at time, and to configure the footswitch to the default Philips configuration. Customers were also instructed to review the information with all members of your staff who need to be aware; retain a copy with the equipment IFU and complete and return the Confirmation Respond form to Mail Stop 4 |
| Quantity | 13297 in total |
| Distribution | Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Demo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002016 | PHILIPS INTEGRIS ALLURA Philips Medical Systems North America, Inc., Sep 6, 2000 |