The GE letter was accompanied by a July 3 notice from the U.S. Food and Drug Administration (FDA), advising U.S. healthcare sites that GE is "voluntarily recalling" the systems. "Serious injuries or deaths could occur due to the failure mode associated with this recall," states a copy of the recall letter obtained by AuntMinnie.com.
The recall follows an accident that occurred on June 5 at the James J. Peters Veterans Affairs Medical Center in New York City, when an Infinia Hawkeye 4 gamma camera collapsed and fell on a patient, killing him.
GE's investigation into the incident has determined that bolts securing the system's camera to its gantry were loose, "thereby stressing the support mechanism and resulting in the incident," according to the recall letter.
Because of the similarities in the design of support mechanisms across many GE products, the FDA has concluded that the following systems should be included in the recall:
- Infinia and Infinia Hawkeye nuclear medicine systems of all types and manufacturing dates
- VG and VG Hawkeye nuclear medicine systems of all types and manufacturing dates
- Helix nuclear medicine systems by Elscint of all types and manufacturing dates (GE acquired Elscint's nuclear medicine business in 1998)
- Brivo NM615, Discovery NM630, Optima NM/CT640, and Discovery NM/CT670 systems, which have been added to the recall "due to similarities in basic mechanical concepts between these devices and the Infinia systems," the FDA letter said
An FDA spokesperson estimated that about 3,400 systems are affected by the recall.
GE originally sent a letter on June 13, the week after the incident, recommending that "qualified service personnel" maintain the equipment and perform preventive maintenance procedures. It then updated that advice with a letter last week advising customers that "all sites cease use of their nuclear medicine system until GE Healthcare can complete an inspection of their individual equipment."
GE engineers will inspect systems to verify that the support mechanism fasteners are secured properly, and sites will be able to resume use of their devices if no issues are found with the support mechanism fasteners, according to Benjamin Fox, GE public relations manager for the U.S. and Canada.
If engineers find an issue with the support mechanism fasteners, GE field service engineers will coordinate the replacement of affected parts and ensure that the system meets all specifications, Fox said in an email to AuntMinnie.com. In these cases, customers should not resume using the camera until the problems have been corrected. GE will fix any affected systems at no cost to customers.
This week's recall is unrelated to a recall of some GE gamma cameras in April 2013. An FDA spokesperson did not have details on that recall as of press time.
The recall is causing a ripple effect internationally, as several regulatory bodies in other countries are advising healthcare providers about the issue. Regulatory authorities in Hong Kong and Australia have issued advisories about the recall.