Company: Naviscan PET Systems
Date of Enforcement Report:10/17/2007
Class:lll
PRODUCT
PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging, Recall # Z-0041-2008
REASON
Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired on the PEMFIex product line. 1. The Positron Emission Mammography Standardized Uptake Value (PEMSUV) and distance measurements for the product mentioned above may be inaccurate if a zoomed image has been opened, measurement tools are used, and the applet remains open while subsequent measurements are being made on another applet (12 slice view). This software defect results in unreliable andlor inconsistent readings in the size, distance between lesions and mass measurement, which could result in the physician selecting inaccurate margins for surgery. 2. In addition, under these same circumstances the Region of Interest (ROI) numbering might not be sequential or multiple regions within the same image might have the same number. Duplicative numbering could result in confusion in definition of the region of interest. 3. When images, user defined as “Other,” are acquired, the thumbnail image is mislabeled as “LCC” (Left Craniocaudal) while the caption contains the correct user-defined labeling. This thumbnail mislabeling could result in reader confusion in the body part being displayed.
RECALLING FIRM/MANUFACTURER
Naviscan PET Systems, San Diego, CA, by telephone and letters on August 1 and 2, 2007 and August 16, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide
