PlainRecalls
FDA Devices Moderate Class II Terminated

GE Healthcare, Discovery MR750w

Reported: July 13, 2016 Initiated: June 8, 2016 #Z-2131-2016

Product Description

GE Healthcare, Discovery MR750w

Reason for Recall

GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. 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. No injury has been reported to GE as a result of this issue.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
471 (184 US; 287 OUS)
Distribution
US: AK, AZ, CA, COM, CT , DC, FL, GA, GU, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH,OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY. OUS: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bermuda Brazil Bulgaria Canada China Egypt France Germany Hungary India Indonesia Ireland Italy Japan Kazakhstan Korea (Republic of) Kuwait Lebanon Mexico Netherlands New Zealand Poland Qatar Romania Russia Russian Federation Saudi Arabia Singapore Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom Uruguay
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
GE Healthcare, Discovery MR750w. Recalled by GE Healthcare, LLC. Units affected: 471 (184 US; 287 OUS).
Why was this product recalled?
GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. 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. No injury has been reported to GE as a result of this issue.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 13, 2016. Severity: Moderate. Recall number: Z-2131-2016.