Open, Classified

Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.

FDA Recall Z-2928-2026 · Posted 2026-08-10

Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Recall StatusOpen, Classified

Product CodeOWB

Date Initiated2026-06-29

Product Quantity4,252 units

Reason for Recall

Firmware issue potentially leading to loss of geometry movements.

Firm Action

Philips notified consignees on about 06/29/2026 via certified mailed letter titled URGENT Medical Device Correction. Consignees were provided instructions to properly identify affected systems and table configurations, instructions for restarting the geometry when the issue occurs, to ensure the notification is distributed to all relevant users and retained with device documentation until corrective actions are completed. Consignees were also instructed to post the notification letter near affected devices for ease of reviewing, notify recipients if affected units were transferred, and to complete and return the provided response form. A Local Philips representative will contact consignees to schedule a visit for the implementation of the software update once available. Philips will address the identified issues by implementing a software update (R8.2.102.1) in all affected systems (FCO72200674). Philips currently expects R8.2.102.1 to be available by Q1 2027, subject to regulatory clearance.

Root Cause

Software design

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Lao, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Vietnam, Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016-12-02 K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016-07-29

Official Source

View FDA Recall →

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