SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner de
FDA device recall Z-0875-2020 · posted 2020-01-28 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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.
- Action taken
- This issue will be resolved by sending an Urgent Medical Device Correction letter to Medical Facility staff (Director of Clinical/Radiology, Risk Manager/Hospital Administrator, Director of Biomedical Engineering) with affected systems. This letter will inform the customer of the issue and instruct the user to ensure the displayed system date is correct. The long-term solution is to correct affected systems with updated software.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LNH
- Quantity 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.
- Date initiated
- 2019-12-23
- Date posted
- 2020-01-28
- Date terminated
- 2020-12-11
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist (K163331) | Ge Medical Systems, LLC | 2017-03-17 |