2/13/98
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.
If you own or operate one of these systems or if you have questions about
the content of this letter, please contact Issues Management Staff, Office of
Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland,
20850, by fax at 301-594-2968, or by e-mail at phann@cdrh.fda.gov.
Sincerely yours,
D. Bruce Burlington, M.D.
Director
Center for Devices and
Radiological Health
Updated February 17, 1998
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