Philips Allura Xper Interventional Fluoroscopic X-ray Systems — Class II medical device recall Z-1144-2024
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2024-02-28, distributed nationwide. Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports ma
| Recall number | Z-1144-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands |
| Recall initiated | 2024-01-02 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00884838054189, 00884838054196, 00884838054202, 00884838054219, 00884838054226, 00884838054240, 00884838059030, 00884838059054, 00884838059061, 00884838059085, 00884838059115, 00884838059122, 00884838059191, 00884838059207, 00884838059269, 00884838080805 |
| Serial numbers | 100, 1000, 1001, 1004, 1005, 1009, 101, 1011, 1014, 1017, 102, 1020, 1022, 1024, 1025, 1028, 1030, 1032, 1034, 1035, 1036, 1038, 104, 1040, 1041 and 475 more |
Product
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: 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 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; 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;
Reason for recall
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
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-1144-2024. 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.