Z-1120-2015Class II

Philips Medical System Allura Xper X-Ray Angiographic

Name: Z-1120-2015 Philips Medical System Allura Xper X-Ray Angiographic
Creator: Philips Medical Systems, Inc.
Published: 2014-06-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-06-06 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of Philips Medical System Allura Xper X-Ray Angiographic on 2014-06-06. FDA classified it as Class II and gives the reason as "In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1120-2015
Classification: Class II
Status: Terminated
Initiated: 2014-06-06
Posted: 2015-03-02
Terminated: 2021-10-15
Recalling firm: Philips North America LLC
Product: Philips Medical System Allura Xper X-Ray Angiographic
Product code: IZI System, X-Ray, Angiographic
Reason for recall: In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.
Root cause tag: software
FDA 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 in commerce: 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
Product codes and lots: Software releases: PBL 10, 20, 30, 40, 50, and 60; CV20; R7.2x; R7.6; R8.1; and R8.2.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1120-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1120-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-02

Product code IZI

K102005Class IIAllura Xper or Table SeriesPhilips Medical Systems North America, Inc. / cleared 2010-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)