PlainRecalls
FDA Devices Moderate Class II Ongoing

1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System

Reported: April 13, 2022 Initiated: February 18, 2022 #Z-0860-2022

Product Description

1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System

Reason for Recall

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

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
653 units
Distribution
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.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System. Recalled by GE Healthcare, LLC. Units affected: 653 units.
Why was this product recalled?
There is potential for the images to be flipped left to right.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0860-2022.