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, HFZ-510, 1350 Piccard
Drive, Rockville, MD 20850, FAX 301-594-2968, or e-mail pzs@cdrh.fda.gov.
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.
Sincerely yours,
D. Bruce Burlington, M.D.
Director
Center for Devices and
Radiological Health
Updated March 13, 1998
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
