Home / Recalls / Medical Devices
Philips Medical Systems Nederlands recalls Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 72203
Recalled June 30, 2021 · FDA recall Z-1904-2021 · Philips Medical Systems Nederlands
Hazard
Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering. · FDA Class II
Units
42 devices
Sold at
Worldwide distribution. US states of: AL, AZ, FL, GA, IL, MA, MO, NJ, OR, and VA; Netherlands, United Kingdom, Poland, Spain, France, Czech Republic, India, Brazil, Singapore, Japan, Colombia, United Arab Emirates, China, Russian Federation, Oman, and Mexico.
Description
Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.
Product
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Manufacturer(s)
Philips Medical Systems Nederlands
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →