Philips Electronics North America Corporation: Medical Device Recall in 2017 - (Recall #: Z-0925-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).

Product Classification:

Class II

Date Initiated: December 1, 2016

Date Posted: February 1, 2017

Recall Number: Z-0925-2017

Event ID: 75845

Reason for Recall:

Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

Status: Terminated

Product Quantity: 2

Code Information:

159, 183

Distribution Pattern:

US: WA OUS: China, Spain, Korea, Republic of, Germany

Voluntary or Mandated:

Voluntary: Firm initiated