Class 2 Device Recall System, Nuclear Magnetic Resonance Imaging

• Date Initiated by Firm: October 03, 2018
• Create Date: October 24, 2018
• Recall Status: Terminated on May 27, 2022
• Recall Number: Z-0236-2019
• Recall Event ID: 81348
• 510(K)Number: K160618
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: SIGNA Architect system; ; Product Usage:; The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
• Code Information: Model number: 5388807-100, Serial number (System ID number ): U30RF0251B (801588MR3), U30RF0258B (M4040093), U30RF0275B (850270504), U30RF0268B (A020MR05)
• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3200 N Grandview Blvd; Waukesha WI 53188-1693
• For Additional Information Contact: 800-437-1171
• Manufacturer Reason for Recall: A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
• FDA Determined Cause: Device Design
• Action: On about 10/03/2018, GE Healthcare sent URGENT MEDICAL DEVICE CORRECTION letters to their consignees informing them of recall and providing safety instructions. Consignees were instructed that they can continue to use the system by following the existing Operator Manual Safety Information for proper patient padding and observation during scanning. The safety information contained in the Operator's Manual includes: 1. WARNING: Place appropriate non-conductive padding between the patient and the bore wherever a portion of the body may come into contact with the magnet opening. 2. CAUTION: Continuous patient observation and contact are required in all modes of operation. 3. CAUTION: Extra attention should be utilized when scanning patients who are unconscious, sedated, or may have loss of feeling in any body part or are physically or mentally impaired and unable to alert the personnel. If a brown discoloration is seen on the inner surface of the patient bore, or if a burning smell is noticed, please contact their local Service Representative. GE Healthcare will contact consignees to arrange for the correction to the devices. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
• Quantity in Commerce: 4 units
• Distribution: Worldwide - US Nationwide Distribution in the state of Utah. International distribution to France, Republic of Korea, and Sweden.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS, LLC