Home / Recalls / Philips Electronics North America Corporation / Z-1589-2018

Z-1589-2018 Class II Terminated

Recalled by Philips Electronics North America Corporation — Andover, MA

FDA device recall Z-1589-2018 was initiated by Philips Electronics North America Corporation on Mar 14, 2018 and is designated Class II. 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. The recall status is terminated (terminated Apr 29, 2024). Affected quantity: 682.

Recall Details

Product Type: Devices
Report Date: May 9, 2018
Initiation Date: Mar 14, 2018
Termination Date: Apr 29, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 682

Product Description

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.

Distribution Pattern

Worldwide Distribution in the states of: 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, and WY. The product was distributed to the following countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Cuba, Czech Republic, Denmark, Estonia, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Republic of Korea, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Caledonia, Norway, Pakistan, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and United Kingdom.

Code Information

Product name: Allura Xper R8.1 .25.0 Allura Xper R8.1 .25.1 Allura Xper R8.1 .25.5 Allura Xper R8.2.25.0 Allura Xper R8.2.25.5 Allura Xper R8.2.27 UNIQ Ri .0.10 UNIQ Ri .0.10.5 Product code: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 7322039, 722058, 722059.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1589-2018
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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