INTEGRIS BV3000 MONO — Class II medical device recall Z-0730-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-02-10, distributed nationwide. The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and s
| Recall number | Z-0730-2016 |
|---|---|
| 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 | 2015-11-03 |
| Classified | 2016-01-30 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2020-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KE, KR, KW, KY, LB, LK, LT, LV, MA, MT, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 13,297 in |
| Model numbers | 72241 |
Product
INTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
Reason for recall
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
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-0730-2016. 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.