Philips North America Llc: Medical Device Recall in 2021 - (Recall #: Z-2343-2021)

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 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: 781342

Product Classification:

Class II

Date Initiated: July 30, 2021

Date Posted: September 1, 2021

Recall Number: Z-2343-2021

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: 3 units US; 17 units OUS

Code Information:

S/N and UDI: 85275 (01)00884838055339(21)85275; 85278 (01)00884838055339(21)85278; 85394 (01)00884838055339(21)85394. OUS: 85393 (01)00884838055339 85332 (01)00884838055339 85334 (01)00884838055339 85336 (01)00884838055339 85349 (01)00884838055339 85350 (01)00884838055339 85355 (01)00884838055339 85370 (01)00884838055339 85371 (01)00884838055339 85382 (01)00884838055339 85384 (01)00884838055339 85385 (01)00884838055339 85398 (01)00884838055339 85348 (01)00884838055339 85149 (01)00884838055339 85367 (01)00884838055339 85388 (01)00884838055339

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