Information Notice No. 98-09: Collapse of an ISOCAM II, Dual-Headed Nuclear Medicine Gamma Camera
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555
March 5, 1998
|NRC INFORMATION NOTICE 98-09:||COLLAPSE OF AN ISOCAM II, DUAL-HEADED NUCLEAR MEDICINE GAMMA CAMERA|
All medical licensees.
The U.S. Nuclear Regulatory Commission is issuing this information notice to alert addressees to the occurrence of an incident involving an Isocam II, dual-headed nuclear medicine gamma camera, manufactured by Park Medical Systems of Quebec, Canada. The reported failure mode under investigation poses a potential for a serious crushing injury to the patient or the technicians using the camera. It is expected that recipients will review the information for applicability to their facilities and consider actions, as appropriate, to ensure safety. However, suggestions contained in this information notice are not NRC requirements; therefore, no specific action nor written response is required.
Description of Circumstances:
The Food and Drug Administration (FDA) issued a Safety Notice on February 13, 1998, to alert users of Isocam II single-head and Isocam II dual-headed nuclear medicine gamma camera systems of a possible design or manufacturing defect that could, cause structured failure and result in serious injury to the patient undergoing testing, or to other personnel using or servicing the camera. The FDA Notice is attached for your information. As indicated in that notice, Park Medical Systems of Quebec, Canada, is no longer in business and, for this reason, owners of such cameras are asked to report any malfunctions that could cause injury directly to the FDA. Owners are also urged to notify FDA of their possession of such a camera so that FDA may forward additional information on the camera as it becomes available.
The device is a radiation detector used to take images of patients injected with radiopharmaceuticals. It contains no radioactive material. The hazard involves physical injury from falling components, not radiation exposure.
This information notice requires no specific action or written response. If you have any questions about the information in this notice, please contact the technical contact listed below.
|Donald A. Cool, Director,
Division of Industrial and Medical Nuclear Safety
Office of Nuclear Material Safety and Safeguards
|Technical Contact:||Steven Baggett, NMSS
|Attachment:||1. Food and Drug Administration Safety Notice|
March 5, 1998
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
February 13, 1998
FDA Safety Notice
Failure of Isocam II, Dual-headed Nuclear Medicine Gamma Camera
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 Paula Simenauer, CDRH, HFZ-510, Piccard Drive, Rockville, MD 20850, FAX 301-594-2968, or e-mail firstname.lastname@example.org.
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