Allura Xper FD2O Biplane — Class II medical device recall Z-3224-2018
Terminated recall by Philips Electronics North America Corporation, reported 2018-10-03, distributed nationwide. There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from t
| Recall number | Z-3224-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2018-07-16 |
| Classified | 2018-09-21 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2022-11-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CA, CH, CL, CN, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 5,115 total |
| Reason classes | device malfunction |
Product
Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Reason for recall
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
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-3224-2018. 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.