Recall Z-0041-2008 ยท KPS System, Tomography, Computed, Emission
Naviscan PET Systems
PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.
| Date | Oct 11, 2007 (initiated Aug 1, 2007) |
| Status | Terminated |
| 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 rema |
| Root cause | Software design |
| 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 beginnin |
| Quantity | 19 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032063 | PEM 2400 PET SCANNER Pem Technologies, Aug 18, 2003 |