Recall Z-1188-2017— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2017-01-20, terminated 2019-09-24. It names 3 FDA 510(k) clearances: K160618, K142085, K132376. Product: Discovery MR450 The systems are whole body magnetic resonance scanners 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.. Reason: Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-20
- Terminated
- 2019-09-24
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
3 on FDA's record- K160618 — Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
- K142085 — DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T
- K132376 — DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Discovery MR450 The systems are whole body magnetic resonance scanners 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.
Reason for recall
Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.
Data sourced from openFDA. This site is unofficial and independent of the FDA.