Philips Medical Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1120-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Philips Medical System Allura Xper X-Ray Angiographic

Product Classification:

Class II

Date Initiated: June 6, 2014

Date Posted: March 11, 2015

Recall Number: Z-1120-2015

Event ID: 70011

Reason for Recall:

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

Status: Terminated

Product Quantity: 7439

Code Information:

Software releases: PBL 10, 20, 30, 40, 50, and 60; CV20; R7.2x; R7.6; R8.1; and R8.2.

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

Voluntary or Mandated:

Voluntary: Firm initiated