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Terminated

GE Healthcare, Discovery MR750w

FDA Recall Z-2131-2016 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2016-06-08
Date Terminated2018-10-04
Product Quantity471 (184 US; 287 OUS)

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.

Firm Action

Consignees were sent on 6/8/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 60901 dated June 8, 2016. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132376DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC) · 2013-11-15K130115DISCOVERY MR750W 3.0TGe Medical Systems, LLC · 2013-05-23K103327DISCOVERY MR750W 3.0TGe Healthcare Japan Corporation · 2011-09-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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