—#168339

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.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K160618
Affected lot / code info: Model number: 5388807-100, Serial number (System ID number ): U30RF0251B (801588MR3), U30RF0258B (M4040093), U30RF0275B (850270504), U30RF0268B (A020MR05)

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3200 N Grandview Blvd, Waukesha, Wisconsin 53188-1693

Distribution

Distribution pattern: Worldwide - US Nationwide Distribution in the state of Utah. International distribution to France, Republic of Korea, and Sweden.

Timeline

Recall initiated: 2018-10-03
Terminated: 2022-05-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168339. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.