Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
Reported: April 13, 2022 Initiated: February 18, 2022 #Z-0857-2022
Product Description
Signa 1.5T TwinSpeed 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
- 10 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? ▼
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System. Recalled by GE Healthcare, LLC. Units affected: 10 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-0857-2022.
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