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| GE Healthcare is warning its customers to stop using certain scanners, including the Infinia Hawkeye 4, over a risk that patients could be crushed.--Courtesy of GE Healthcare |
GE Healthcare ($GE) is urging customers to stop using more than 20 models of its nuclear imaging devices until the company can inspect each one and ensure it's not prey to the same problem that killed a patient in the U.S. last month.
In June, GE got word that a patient died after bolts came loose on an Infinia Hawkeye 4 device, dropping the attached camera and killing the patient.
In the weeks after the incident, GE warned customers to avoid using Infinia scanners until company inspectors could come around and ensure they were safe. This month, GE has updated the recall to include all of its nuclear medicine systems, saying that design similarities between all of the devices could put patients at risk if left uninspected.
The FDA has assigned its most-serious Class I label to the recall, reserved for malfunctions that can lead to serious injury or death. The agency is asking customers and patients to report any related adverse events through its online MedWatch system.
Neither GE nor the FDA specified how many devices around the globe are affected by the recall, and the company hasn't said how long the system-by-system inspection process will take.
GE didn't respond to specific questions Monday but said in a statement that it expanded the scope of its action to ensure "a high level of safety and quality," recommending all sites suspend use of the devices until it can ensure they are properly secured.
"(The company) is dedicating resources to these activities so that the global installed base inspection activities can be completed appropriately and as quickly as possible," according to a statement.
Included in GE's warning are the Infinia, Varicam and Millennium VG scanners, systems installed in hospitals around the world and used for oncology, cardiology, neurology and other clinical diagnostics.
- read GE's letter (PDF)
- check out the FDA's note
Editor's note: This story has been updated to include a statement from GE Healthcare.