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.
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