GE Healthcare, LLC: Medical Device Recall in 2022 - (Recall #: Z-0857-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Signa 1.5T TwinSpeed Magnetic Resonance Imaging System

Product Classification:

Class II

Date Initiated: February 18, 2022

Date Posted: April 13, 2022

Recall Number: Z-0857-2022

Event ID: 89720

Reason for Recall:

There is potential for the images to be flipped left to right.

Status: Ongoing

Product Quantity: 10 units

Code Information:

System IDs: MMIMR01, 213748HDMR, 714125MR, 561218MR1, 918523MR1,304766MR1, 082427030026, 082427080007, 082427020017, 376569401MR

Distribution Pattern:

Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated