Philips Allura Xper FD series with Software Version Number: 2 — Class II medical device recall Z-0416-2022
Terminated recall by Philips North America Llc, reported 2021-12-29, distributed nationwide. Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Mon
| Recall number | Z-0416-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2021-11-19 |
| Classified | 2021-12-22 |
| Reported by FDA | 2021-12-29 |
| Terminated | 2024-02-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | DO, ES, IN, JP, PL, TW |
| UPC / GTIN / UDI-DI | 00884838054189, 00884838054196, 00884838054202, 00884838059030, 00884838059054, 00884838059191 |
| Model numbers | 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028 |
Product
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.
Reason for recall
Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.
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-0416-2022. 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.