FDA Medical devices recall · August 6, 2025

Philips Allura R8.2.x Systems recall

Read the official FDA notice ↗

Product

Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.

Why was it recalled?

Potential for temporary loss of imaging (X-ray) functionality due to software issue.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Software Verion: R8.2.x. Model Number [UDI Numbers]: 1. 722026 [(01)00884838054189(21)765, (01)00884838054189(21)156, (01)00884838054189(21)253, (01)00884838054189(21)287, (01)00884838054189(21)825, (01)00884838054189(21)394, (01)00884838054189(21)713, (01)00884838054189(21)465, (01)00884838054189(21)74, (01)00884838054189(21)462, (01)00884838054189(21)192, (01)00884838054189(21)191, (01)00884838054189(21)522, (01)00884838054189(21)204, (01)00884838054189(21)155, (01)00884838054189(21)1132, (01)00884838054189(21)967, (01)00884838054189(21)205, (01)00884838054189(21)1246, (01)00884838054189(21)122, (01)00884838054189(21)259, (01)00884838054189(21)185, (01)00884838054189(21)618, (01)00884838054189(21)531, (01)00884838054189(21)855, (01)00884838054189(21)235, (01)00884838054189(21)805, (01)00884838054189(21)725, (01)00884838054189(21)832, (01)00884838054189(21)368, (01)00884838054189(21)646, (01)00884838054189(21)653, (01)00884838054189(21)663, (01)00884838054189(21)965, (01)00884838054189(21)258, (01)00884838054189(21)602, (01)00884838054189(21)908, (01)00884838054189(21)959, (01)00884838054189(21)221, (01)00884838054189(21)1129, (01)00884838054189(21)973, (01)00884838054189(21)664, (01)00884838054189(21)778, (01)00884838054189(21)109, (01)00884838054189(21)110, (01)00884838054189(21)116, (01)00884838054189(21)512, (01)00884838054189(21)115, (01)00884838054189(21)284, (01)00884838054189(21)389, (01)00884838054189(21)841, (01)00884838054189(21)223, (01)00884838054189(21)694, (01

Distribution

Worldwide - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Georgia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, 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.

States: Georgia

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2189-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.