As a follow-up to a February 13, 1998 FDA Safety Notice, we are informing you of additional information obtained regarding the recent failure of an Isocam II, dual-headed nuclear medicine gamma camera (also available as a single-head system), manufactured by Park Medical Systems, Quebec, Canada. The U.K. Medical Devices Agency (MDA) and Park Medical Systems (U.K.) Ltd. have now received a preliminary failure analysis of this incident. They have concluded that the Isocam II is unsafe for clinical use and will require engineering modifications to render it safe. Because Park U.K. does not conduct business in the U.S., this report is not available to the FDA. In the absence of any other analysis, the FDA recommends the immediate removal of the Isocam II from service until further notice.
This incident continues to be investigated by the U.K. MDA and Park U.K. We will report any further findings as they become known. If you own or operate one of these camera systems, please notify the FDA, so we can forward this new information to you by contacting Paula Simenauer, CDRH, 10903 New Hampshire Ave., WO-66 Room 5437, Silver Spring, MD 20993, or e-mail email@example.com.
The Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other user facilities to report deaths, serious illnesses, and injuries associated with the use of medical devices, including gamma cameras. Practitioners should follow the procedures established by their facility for such mandatory reporting.
We also encourage you to report to FDA's MedWatch program those problems and malfunctions not required to be reported under SMDA. You may reach 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.
Should you have any questions about the content of this notice, please contact Paula Simenauer at the above address.
D. Bruce Burlington, M.D.
Center for Devices and Radiological Health
Food and Drug Administration