Allura Xper FD20/20 — Class II medical device recall Z-0713-2016
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-0713-2016 |
|---|---|
| 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 | 722038 |
Product
Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
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
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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.