Philips North America Llc: Medical Device Recall in 2021 - (Recall #: Z-2345-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 78127 (OUS)

Product Classification:

Class II

Date Initiated: July 30, 2021

Date Posted: September 1, 2021

Recall Number: Z-2345-2021

Event ID: 88461

Reason for Recall:

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

Status: Terminated

Product Quantity: 11 units

Code Information:

S/N and UDI: 78189 (01)00884838068452; 78272 (01)00884838068452; 78294 (01)00884838068452; 78295 (01)00884838068452; 78332 (01)00884838068452; 78335 (01)00884838068452; 78340 (01)00884838068452; 78345 (01)00884838068452; 78249 (01)00884838068452; 78324 (01)00884838068452; 78326 (01)00884838068452

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated