FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: Philips Medical System Allura Xper X-Ray Angiographic
- Recall number
- Z-1120-2015
- Recalling firm
- Philips Medical Systems, Inc.
- Product
- Philips Medical System Allura Xper X-Ray Angiographic
- Status
- Terminated
- Initiated
- 2014-06-06
- Posted
- 2015-03-02
- Terminated
- 2021-10-15
- 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 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.
- 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, 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
- Lot, serial or model codes
- Software releases: PBL 10, 20, 30, 40, 50, and 60; CV20; R7.2x; R7.6; R8.1; and R8.2.
- 510(k) numbers
- K102005
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28