Allura Xper R8 — Class II medical device recall Z-1589-2018
Terminated recall by Philips Electronics North America Corporation, reported 2018-05-09, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. After continuous operation for more than one and a half days, the image on the large screen monitor may freeze
| Recall number | Z-1589-2018 |
|---|---|
| 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 | 2018-03-14 |
| Classified | 2018-05-01 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2024-04-29 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CZ, DE, DK, EE, ES, FR, GB, HK, HR, HU, ID, IE, IL, IN, IT, JP, KR, MA, MX, MY, NL, NO, PK, PL, QA, RO, RU, SA, SE, SG, TH, TN, TR, TW, ZA |
| Quantity | 682 |
Product
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, eg peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placement, embolization and thrombolysis. Cardiac imaging applications including diagnostics, interventional minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper ED series is compatible with a hybrid operating room.
Reason for recall
After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.
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-1589-2018. 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.