PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.

FDA device recall Z-0041-2008 · posted 2007-10-11 · Terminated

Recall details

Recalling firm

Naviscan PET Systems

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

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

KPS

Quantity affected

19 units

Distribution

Nationwide.

Date initiated

2007-08-01

Date posted

2007-10-11

Date terminated

2008-05-14

Location

San Diego, CA

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