Healthcare regulators in the U.K. revived a 10-year-old equipment concern regarding certain Carestream Health intra-oral dental X-ray units, warning that there may be devices out there that haven’t received necessary "modification" to mitigate a falling equipment risk.
The X-ray systems, manufactured by Trophy, which is now owned by Carestream, were the subject of warnings issued in 1995 and 2000, but ongoing surveillance and recent investigations into breakages showed that not all devices received the maintenance they required, according to a safety notice issued by Carestream.
The affected devices are nearing "the end of useful life," having been manufactured between 1990 and 1994 and discontinued since 2006, according to the notice.
The warning was handled through an FDA alert over 10 years ago, a Carestream spokesperson told MassDevice.com. The FDA hasn’t issued a new alert on the potentially faulty mounting brackets.
Carestream is offering customers the option to trade in their potentially out-dated X-ray systems, given that service contracts on the affected devices expired in 2012.
The renewed concern about falling equipment may have been partly spurred by a recent patient death at a New York Veterans Administration hospital, where a patient was crushed after part of a GE Healthcare (NYSE:GE) Infinia Hawkeye 4 nuclear medicine system collapsed.
Experts said the accident was extremely rare, but GE Healthcare nonetheless issued a wide-scale warning, asking healthcare providers cease use of a series of nuclear medicine systems while the company comes around to conduct inspections.