|Magnetic rundown unit with arrows pointing to its subcomponents--Courtesy of FDA|
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.
"At certain sites, the MRU (magnetic rundown unit) 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," the recall notice says.
In a formal release about the recall issued on Feb. 25, the FDA says that the disabled MRU units resulted in "two reported injuries when hospital employees entered the MRI room carrying a metal container."
The original recall notice blames the problem on poor training or employee error. "The FDA is recognizing that this wasn't caused by a product or an equipment malfunction," a GE spokeswoman said in an email to FierceMedicalDevices.
|The Discovery MR750 is one of several GE MRI systems being recalled.--Courtesy of GE|
The FDA says GE sent customers a letter in January urging them to ensure that the MRU is connected to the magnet by performing a four-part test. "This test is an action that GE Healthcare currently advises users to do on a regular basis," GE said in the email.
The FDA says 12,968 devices are affected including 7,260 outside the U.S. in several countries from Albania to Zambia.
In addition, the FDA concurrently posted another Class I MRI recall on its website. Ohio's Alltech Medical Systems is recalling 2 Echostar Spica MRI systems in Maryland because "the MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly."
Both recalls are ongoing.
- read the FDA recall notice | read the Alltech Medical recall notice
- here's more on the recall from FDA
- here's GE's recall announcement | here's another GE statement
- for more, check out the FDA's database of reported adverse events for all nuclear magnetic resonance imaging systems
Editor's Note: This article has been updated with comments from GE Healthcare and additional information released by the FDA.