FDA Device Recall Z-0041-2008: Naviscan PET Systems

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0041-2008.

Recall Res Number

Z-0041-2008

Recalling Firm / Manufacturer

Naviscan PET Systems

FEI Number

3005945241

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-08-01

Date Posted

2007-10-11

Date Terminated

2008-05-14

Product Code

KPS

Event Number

44791

Product Quantity

19 units

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

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 Details 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.

Distribution Pattern Nationwide.

Code Information / Serial Numbers 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

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Medical Device Recall: Z-0041-2008

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer