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Terminated

GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.

FDA Recall Z-0553-2016 · Posted 2015-12-28

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeMOS
Date Initiated2015-12-07
Date Terminated2018-11-08
Product Quantity90 (54 US; 36 OUS)

Reason for Recall

Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.

Firm Action

Consignees were sent on 12/7/2015 a GE Healthcare "Urgent Medical Device Correction" GEHC Ref#60888 letter dated December 7, 2015. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, 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. UPDATE: Consignees were sent a revised letter on May 2, 2016. Previously the letter only listed MR750W Surgical Suite Scanners. Because 3.0T 6 Channel Flex Coils are used with the MR750, MR750W, and 3.0T HDxT (including HD23), these devices have been added to the letter. There are no other changes to the letter. UPDATE 5/27/16: Consignees were sent a revised letter on May 19, 2016. The letter topic stated "De-rating of 3.0T 6 Channel Flex Coil when used on Discovery MR750 running DV24, DV25, or DV25.1 Application Software" . The letter described the Safety Issue, Safety Instruction, Affected Product details, Product Correction and Contact Information (same as previous letter).

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution- US Distribution including the states of AZ, CA, CO, IL IN, MI, MN, NY, OH, OK, SD, TX, WI, VA, DE, FL, MD, ME, MO, NC, NH, OR, PA, TN, WI, DC, PR and the countries of CANADA, CHINA, CZECH REPUBLIC, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, PORTUGAL, ROMANIA, SOUTH AFRICA, SWITZERLAND, TURKEY, SWEDEN, AUSTRALIA, BRAZIL, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, ITALY, MEXICO, RUSSIA, SAUDI ARABIA, TAIWAN, UNITED KINGDOM, INDONESIA, ESTONIA, REPUBLIC OF KOREA, POLAND, KUWAIT, SPAIN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1106101.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COILGe Medical Systems, LLC · 2011-04-01

Official Source

View FDA Recall →

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

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