February 13, 1998
TO: Nuclear Medicine Imaging Facilities
FDA has recently become aware of a malfunction, with potential for serious injury, involving an Isocam II, dual-headed nuclear medicine gamma camera (also available as a single-head system), manufactured by Park Medical Systems of Quebec, Canada. A stainless steel plate from a harmonic drive motor failed, causing an arm of the system to fall into the gantry housing of the device. No collimator was on the camera at the time and no patient or operator was injured.
The cause of this incident is under investigation by the U.K., Medical Devices Agency and Park U.K. We will report the findings once they become known; but we are unable to offer any recommendation at this time.
Adverse event reports related to device malfunctions that could cause or contribute to a serious injury are usually submitted to the device manufacturer. As Park Medical Systems is no longer in business, adverse event reports on the Isocam II camera should be submitted to FDA. In addition, if you own or operate one of these systems, please notify the FDA, at the address below, so that we can forward new information to you.
Please also be advised that the Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other user facilities to report deaths and serious illnesses and injuries associated with the use of medical devices. Practitioners should follow the procedures established by their facility for such mandatory reporting.
We encourage you to report directly to MedWatch, FDA's voluntary reporting program, those problems and malfunctions not required to be reported under SMDA. You may report to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane (HF-2), Rockville, MD 20857.
FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.
D. Bruce Burlington, M.D.
Center for Devices and Radiological Health
Food and Drug Administration