Radiosurgery devices maker Accuray (NSDQ:ARAY) released an official statement on the recall of a pair of components of its CyberKnife radiosurgery systems, warning that the devices were not manufactured to standard.
Accuray warned that the Iris variable aperture collimator and the RoboCouch patient positioning system, which were manufactured by 3rd party suppliers, must be removed from affected systems because they failed to meet company quality requirements. No adverse events were reported in connection with the recalled components, the company said.
The Sunnyvale, Calif.-based medical device maker said its removing about 176 units of its collimators and 16 units of the positioning systems, according to a press release.
The affected collimators were associated with a defect that "could potentially result in a shift to the central axis of the radiation beam, posing a potential clinical impact to plans created using the smallest collimators," Accuray reported. The positioning systems housed gear boxes that may be defective, and all those gear boxes have been replaced.
The FDA gave the recall Class II status, noting that the systems are in worldwide distribution, including in the U.S., Canada, England, Mexico and more.
ARAY shares sank as low as $4.26 in morning trading today, after opening at $4.39. Share prices clawed back some of those losses but was still down 2.5% as of about 1:35 p.m. when shares were trading at $4.33.
To date there are 2 adverse CyberKnife events reported to the FDA’s MAUDE reporting system, both reported for April 15, 2013, and apparently unrelated to the recall. One describes a patient who "experienced complications" while enrolled in a non-Accuray sponsored study. The patient suffered injury, but the physician indicated that there was no malfunction in the device, according to the report.
"Due to the nature of the follow up intervention, and the lack of related details, this is being reported," according to the MAUDE report.
The 2nd MAUDE report was the result of an adverse event noticed by an employee reviewing a draft clinical publication, in which a patient developed steroid-refractory radiation pneumonitis 8 months after treatment and died 4 months after that.
"The complication is a known risk of treating a tumor within the given treatment parameters and tumor location," according to the report. "The physician indicated that the planned treatment was delivered as intended and that the [adverse event] was not due to a malfunction of the device."