Allura Xper FD20; Model Number: 722012;
FDA Device Recall #Z-1070-2026 — Class II — December 15, 2025
Recall Summary
| Recall Number | Z-1070-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 15, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Location | Best |
| Product Type | Devices |
| Quantity | 79 units |
Product Description
Allura Xper FD20; Model Number: 722012;
Reason for Recall
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.
Lot / Code Information
Model Number: 722012; System Product Name: Allura Xper FD20; UDI-DI: 00884838059054; Serial Numbers: 2942, 1515, 1189, 1594, 535, 1964, 2156, 2742, 2092, 1673, 1803, 1655, 2020, 1973, 2037, 1853, 2098, 1248, 1082, 1576, 1057, 1129, 646, 930, 1421, 462, 203, 627, 2005, 1428, 353, 288, 191, 1994, 1802, 156, 853, 1283, 1956, 2361, 1980, 872, 931, 1295, 2513, 1090, 1374, 468, 1822, 812, 1379, 1817, 1580, 1050, 309, 144, 1841, 1845, 1468, 558, 1968, 1959, 2168, 1168, 1562, 967, 2114, 47, 167, 2091, 2053, 604, 603, 217, 2918, 373, 850, 1820, 1821, 1619;
Other Recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2258-2026 | Class II | Azurion system; System Code Description (Model ... | Apr 30, 2026 |
| Z-2259-2026 | Class II | Allura system; System Code Description (Model N... | Apr 30, 2026 |
| Z-2227-2026 | Class II | Azurion system; System Code Description (Model ... | Apr 28, 2026 |
| Z-2229-2026 | Class II | Integris-Allura system; System Code Description... | Apr 28, 2026 |
| Z-2225-2026 | Class II | Philips Azurion systems not configured with an ... | Apr 28, 2026 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.