Terminated

Philips Medical System Allura Xper X-Ray Angiographic

FDA Recall Z-1120-2015 · Posted 2015-03-02

Recalling FirmPhilips Medical Systems, Inc.

Recall StatusTerminated

Product CodeIZI

Date Initiated2014-06-06

Date Terminated2021-10-15

Product Quantity7439

Reason for Recall

In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.

Firm 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 malfunction. 3. Philips Healthcare Field Service Engineers will schedule an appointment with customers to install the software update. 4. The software solutions will be rolled out consecutively, each within a maximum completion time of 6 months. The software releases will be corrected in descending order of the number of affected systems in the field, with approximately 80% of the total installed base corrected by 4 2015.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

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, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Reunion, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Saudi Arabia, Switzerland, Syria, Taiwan, Thailand, France, Dominican Republic, Colombia, Turkey, Germany, Greece, Hong Kong, Denmark, Ecuador, Egypt, Estonia, Finland, Vietnam, Russian Federation, Iran, Iraq, Ireland, Israel, Italy, India, Indonesia, Japan, Jordan, Kenya, South Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Moldavia, Mongolia, Morocco, Nepal, Ukraine, United Arab Emirates, and United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102005ALLURA XPER OR TABLE SERIESPhilips Medical Systems North America, Inc. · 2010-08-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.