—#178945

Product

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.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K163331
Affected lot / code info: Mfg. Lot or Serial # System ID PG75A1700023MR 630DMGMR3T 33-4-1252 312702MR3T 033-4-1005 518262MR750W To be provided 082427210212 To be provided 082427170026 To be provided GON4713311 To be provided M4017073 To be provided EM0601 To be provided O009MR03 To be provided GON4634845

Why it was 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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Timeline

Recall initiated: 2019-12-23
Posted by FDA: 2020-01-28
Terminated: 2020-12-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178945. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.