GE Quench: FDA Issues Class 1 Device RECALL For 13,000 Scanners!

AuntMinnie.com reports an FDA recall of about a zillion GE MRI’s and other brands with GE components (well, actually, it’s only 13,000 of them):

The U.S. Food and Drug Administration (FDA) has ordered a recall of thousands of MRI scanners manufactured by GE Healthcare to correct a problem that could “result in life-threatening injuries” if magnet shutdown modules are disconnected, according to an FDA notice.

In the notice, dated February 18, the FDA announced that it has ordered a class I device recall of all GE MRI scanners using superconducting magnets. The recall covers some 33 brand names of scanners and thousands of systems distributed throughout the world, manufactured from 1985 to today.

The notice describes the problem as pertaining to the systems’ magnet rundown units (MRUs), which are designed to initiate a controlled quench and turn off the magnetic field in the event of certain problems with the scanner, such as a ferromagnetic object introduced into the MRI suite. Such shutdowns are only intended for extreme emergencies and can put an MRI magnet out of commission for a week or more and cost up to $30,000 to replace lost helium, according to the website MRIQuestions.com.

In GE’s case, a scanner’s magnetic rundown unit may not actually be connected to the scanner, according to the FDA recall notice. In an emergency, a disconnected MRU “could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries,” the notice said.

You can find the FDA notice HERE. You’ll have to scroll through thousands of serial numbers to get to the meat of the notice:

Manufacturer Reason
for Recall
At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.
FDA Determined
Cause 2
TRAINING: Employee Error
Action 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.

Quantity in Commerce 12,968 (5,708 US, 7,260 OUS).
Distribution Worldwide Distribution – US Nationwide in all states in continental USA including DC, PR, GU, and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR,K ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE , UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM, ZAMBIA.

Oops. Did I see employee error listed as the problem? AuntMinnie’s Brian Casey notes:

The company said it learned of the problem after discovering that some MRI scanners in India had been modified by service personnel or by equipment users to disable the magnet rundown unit. In addition to alerting customers to the problem, GE noted that the red magnet rundown button should only be pressed in an emergency situation.

Now why, one might ask, would anyone want to disable the MRU? Inquiring minds want to know. And did we really need the reminder that the big red button that says, “PRESS IN CASE OF EMERGENCY” should be pressed only in an emergency? Perhaps that tells us something about GE’s opinion of its customers.

Mobile MRI services take note…business awaits!


via Blogger http://ift.tt/1z4n3rv February 19, 2015 at 06:18PM

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