Allura system — Class II medical device recall Z-2228-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2026-05-27, distributed nationwide. The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020,
| Recall number | Z-2228-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands |
| Recall initiated | 2026-04-28 |
| Classified | 2026-05-21 |
| Reported by FDA | 2026-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LK, LT, LV, MA, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00884838054189, 00884838054196, 00884838054202, 00884838054219, 00884838054226, 00884838054240, 00884838059030, 00884838059047, 00884838059054, 00884838059061, 00884838059085, 00884838059108, 00884838059115, 00884838059122 |
| Serial numbers | 01H041985, 1000, 1007, 102, 103, 1038, 104, 1044, 1061, 109, 1090, 1094, 1106, 118, 1187, 1192, 1197, 122, 1223, 123, 1232, 124, 1242, 125, 1259 and 339 more |
| Model numbers | 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722023, 722025, 722026, 722027, 722028, 722029, 722035, 722038, 722058, 722059 |
Product
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
Reason for recall
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2228-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.