Z-0129-2021 Class II Terminated
FDA device recall Z-0129-2021 was initiated by GE Healthcare, LLC on September 8, 2020 and is designated Class II. Reason for recall: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. The recall status is terminated (terminated April 28, 2021). Affected quantity: 30 Devices total.
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2020
- Initiation Date
- September 8, 2020
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 Devices total
Product Description
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Reason for Recall
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.
Code Information
Model: 5352293, 5726207-5, 5741000-25 and 5741000-29 .