UPDATED: Nearly 10,000 GE, Siemens MRI machines under FDA recall
|The Discovery MR750 is one of several GE MRI systems being recalled.--Courtesy of GE|
Almost 10,000 GE ($GE) and Siemens MRI machines are being recalled, the FDA's database shows. The agency classified the recalls in its second-most severe category, meaning the affected machines "may cause temporary or medically reversible adverse health consequences."
More than 9,000 GE Signa, Discovery and Optima MRIs were recalled because "of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites."
The company sent a letter to affected customers on March 9 describing the safety issue and safety instructions, the recall notice says. The corrective action is "a 5-minute, free, double-check of the software version on the MRI system, performed by a GE Field Engineer. It's similar to checking for an iPhone software update. There is no impact on usage of the MRI," a representative of GE said in an email to FierceMedicalDevices.
Almost 3,000 of the affected MRIs are in the U.S., with the rest located in countries throughout the globe.
This is the second GE MRI recall of the year. In February, FierceMedicalDevices broke the news of a Class I recall of all GE MRI machines manufactured since 1986, or 12,968 machines. The FDA says Class I recalls are for situations "in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." It was the first Class I MRI recall since at least 2007, according to the FDA database.
In that recall, GE became aware of a situation in which a magnetic rundown unit was not connected to the device's magnet, resulting in "two reported injuries when hospital employees entered the MRI room carrying a metal container," according to the FDA. The company responded by sending customers a letter in January urging them to ensure that the MRU is connected to the magnet by performing a four-part test.
Meanwhile, Siemens recalled 132 of its Magnetom MRI systems earlier this month due to a component that was nonconforming the FDA's Good Manufacturing Practice regulations. "The gradient output supervision was permanently turned off on the Magnetom system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur," the recall notice says.
A letter was sent to customers March 6 to inform them of the issue and what measures were being taken to mitigate the risks.
The Magnetom can be used in the traditional manner for diagnosis, or during an interventional procedure when used in conjunction with MRI-compatible displays and MRI-safe devices, the FDA says.
This is Siemens' first MRI-related recall of 2015.
According to the FDA database, magnetic interference is the most common problem with MRI machines, with 39 complaints, followed by three complaints of a connection issue.
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Editor's Note: This article has been updated with additional information from a GE representative.