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U.S. Department of Health and Human Services

Class 3 Device Recall PEMView

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 Class 3 Recall
PEMView
see related information
Date Posted October 11, 2007
Recall Status1 Terminated on May 14, 2008
Recall Number Z-0041-2008
Recall Event ID 44791
Premarket Notification
510(K) Number
K032063 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.
Code Information Serial numbers: C3, P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P14, P002-B-070119-01, P002-B-070316-01, P002-B-070423-01, P002-B-070531-01, P002-B-070629-01, P002-B-070712-01
Recalling Firm/
Manufacturer
Naviscan PET Systems
11180 Roselle St Ste A
San Diego, California 92121-1211
For Additional Information Contact Heather Jalisi
858-587-3641 Ext. 114
Manufacturer Reason
for Recall
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 rema
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action Telephone notification regarding issues #1 and #2 were carried out on August 1 and 2, 2007 and included instructions for a validated work-around to avoid the software issues. Written notifications with these same validated work-around instructions were sent on August 2, 2007 via certified mail. Customers were notified that Naviscan has identified a potential safety issue with all versions of PEM View Software. Issue #3 was identified after the notification to customers for issues #1 and #2. Telephone notification regarding issues #3 was carried out via telephone and certified mailing beginning August 16, 2007. Customers were informed that Naviscan is preparing software to resolve these issues and that they would be contacted by Naviscan Customer Support to ensure they thoroughly understand the issues and the recommended procedure to prevent these issues from occurring. If customers have any questions they were instructed to contact Naviscan Customer Support at 1-888-628-4159 or service@navsicanpet.com.
Quantity in Commerce 19 units
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = PEM TECHNOLOGIES
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