Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
USAllura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Recalling Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Reason for Recall / Hazard
Firmware issue potentially leading to loss of geometry movements.
Product Description & Identification
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Affected Products
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Additional Source Details
| Field | Value |
|---|---|
| City | Best |
| Event id | 99378 |
| Address 1 | Veenpluis 6 |
| Code info | Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)00884838059115(21)100, (01)00884838059115(21)239, (01)00884838054202(21)520, (01)00884838054202(21)1956, (01)00884838054189(21)683, (01)00884838054196(21)351, (01)00884838054202(21)129, (01)00884838059115(21)305, (01)00884838054196(21)332, (01)00884838054202(21)1233, (01)00884838054202(21)2206, (01)00884838054202(21)1690, (01)00884838054202(21)928, (01)00884838054189(21)155, (01)00884838054202(21)317, (01)00884838054202(21)1774, (01)00884838054202(21)2502, (01)00884838054202(21)869, (01)00884838054202(21)668, (01)00884838054189(21)618, (01)00884838054189(21)1051, (01)00884838054189(21)1052, (01)00884838054202(21)406, (01)00884838054202(21)540, (01)00884838054202(21)548, (01)00884838054202(21)1017, (01)00884838054202(21)590, (01)00884838054189(21)654, (01)00884838054189(21)786, (01)00884838054196(21)216, (01)0088... [TRUNCATED] |
| Postal code | N/A |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 4,252 units |
| Reason for recall | Firmware issue potentially leading to loss of geometry movements. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260629 |
| Initial firm notification | Letter |
| Center classification date | 20260810 |
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Overview
- Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.
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🚨 SAFETY ALERT: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system. Check if your household is affected: https://therecallfile.com/recalls/allura-xper-fd-model-numbers-722026-722027-722028-722029-722035-722038/FDA-Z-2928-2026
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