Thursday, February 19, 2015

GE recalls 10,000+ MRI systems after FDA deems them potentially deadly, citing poor training





The FDA just deemed all GE Healthcare ($GE) MRIs with superconducting magnets potentially deadly by classifying the recall of nearly 13,000 of the imaging systems into the most serious Class I category. This means there is a reasonable probability that the device "will cause serious adverse health consequences or death."


The recall covers about 25 different MRIs, including several versions of the Signa brand and three versions of the Discovery brand. The notice posted on the FDA website on Feb. 18 also contains the affected lot and serial numbers, as well as the system ID.



The Discovery MR750 is one of several GE MRI systems being recalled.--Courtesy of GE


The notice includes these instructions and test procedures

GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 60876 dated January 6, 2015 to affected consignees. 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 & Contact Information. Customers were instructed to do the following: As a preventative measure, confirm that MRU is connected to the magnet by performing the following four step test on the MRU. 1. Verify the green CHARGER POWER LED is lit. 2. Depress and hold the TEST BATTERY switch for 15 seconds. The green BATTERY TEST LED should light and remain lit while the TEST BATTERY switch is depressed. 3. Place the TEST HEATER toggle switch in the A position. The green HEATER TEST LED should light. If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning. 4. Place the TEST HEATER toggle switch in the B position. Green HEATER TEST LED should light. If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning. If the MRU test does not perform as described in each of the 4 steps above, GEHC strongly recommends that you stop using the system, and immediately call your GEHC representative. Customers with questions may contact their local service representative. For questions regarding this recall call 262-513-4122.

Digital  Health Space is carrying this announcement as an urgent medical device safety warning.  Further questions should be addressed to your local provider(s)






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