SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Reported: February 5, 2020 Initiated: December 23, 2019 #Z-0875-2020
Product Description
SIGNA Architect Nuclear Magnetic Resonance Imaging System - 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
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 62 (30 US, 32 OUS) total devices
- Distribution
- Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.. Recalled by GE Healthcare, LLC. Units affected: 62 (30 US, 32 OUS) total devices.
Why was this product recalled? ▼
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2020. Severity: Moderate. Recall number: Z-0875-2020.
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