Z-0236-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2018
- Initiation Date
- October 3, 2018
- Termination Date
- May 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
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.
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.
Distribution Pattern
Worldwide - US Nationwide Distribution in the state of Utah. International distribution to France, Republic of Korea, and Sweden.
Code Information
Model number: 5388807-100, Serial number (System ID number ): U30RF0251B (801588MR3), U30RF0258B (M4040093), U30RF0275B (850270504), U30RF0268B (A020MR05)