FDA recall Z-1904-2021

Product

Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2016-06-23

Report date

2021-06-30

Termination date

2023-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Best, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1904-2021