Single safety incident caused the issue that could present major risk to patients.
It was human, not mechanical error, that sparked last week's recall notice of close to 13,000 MRI devices , GE Healthcare said on Tuesday.
In fact, GE said the U.S. Food and Drug Administration recall was in response to the single safety incident in India, according to the company’s statement.
While GE Healthcare did not release details of the error, it gave instructions to MRI customers to perform a five-minute check to ensure no one has disconnected the machine’s magnetic rundown unit, or MRU, which is effectively an “emergency off switch” for the magnet.
The five-minute check is the substance of the recall notice. The MRIs are not being returned and replaced, according to GE Healthcare.
The MRU must be connected to the magnet at all times, the FDA said in its recall notice. A disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injury, the FDA said.
The FDA gave the recall its most urgent classification because of the possibility of a high-risk event, but no incident of patient harm has been reported.
Last week, GE and the U.S. FDA issued the Class I recall of 12,968 MRI systems worldwide, including more than 5,000 in the United States, after GE discovered problems with the MRU connection that controls the magnetic field and must be shut down in a patient emergency.GE Healthcare had told customers of the problem in January. The FDA recall was issued out of concern for potentially life-threatening results from a non-functioning part of the device.
Each MRI ranges in price from $700,000 to $2.5 million, according to the company.
GE recommends that staff confirm the MRU is connected to the magnet through a four-step test involving the charger, battery and test heater. If at any step the MRU isn’t working, healthcare workers should stop using the machine and contact company representatives, GE said.
The five minute check ensures no one has disconnected the MRU, GE said. It is a common industry practice to have an “emergency off switch” for the magnet, according to GE.
GE recommends the check be done weekly and once confirmed, MRI operations can continue as normal.