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U.S. Department of Health and Human Services

Class 2 Device Recall Naviscan PET Systems Inc ("Naviscan") PEM Flex Solo II PET Scanner.

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 Class 2 Recall
Naviscan PET Systems Inc ("Naviscan") PEM Flex Solo II PET Scanner.
see related information
Date Posted September 11, 2008
Recall Status1 Terminated on March 13, 2009
Recall Number Z-2229-2008
Recall Event ID 48694
Premarket Notification
510(K) Number
K032063 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology.
Code Information Serial Numbers: P002-B-070316-01, P002-B-070423-01, P002-B-070531-01, P002-B-070629-01, P002-B-070712-0l, P002-B-070718-01, P002-B-070910-01, P002-B-070911-01, P002-B-071015-01, P002-B-080107-01, P002-B-080108-01, P002-B-080207-01, and P002-B-080307-01
Recalling Firm/
Manufacturer
Naviscan PET Systems
11180 Roselle St Ste 100
San Diego, California 92121-1211
For Additional Information Contact Heather Jalisi
858-332-0942
Manufacturer Reason
for Recall
This field correction is being initiated as a result of the firm's investigation into a report from a user indicating that the motorized compression exceeded 25 pounds of compression force during the pre-scan positioning of the patient. The investigation identified that a secondary fault protection did not perform as expected.
FDA Determined
Cause 2
DESIGN: Device Design
Action An Urgent Medical Device Field Correction Notice was sent to all PEM Flex Solo II customers about this issue via Federal Express Priority Service on June 19, 2008. Customers were informed of the: (1) Issue: Potential for motorized compression to exceed 25 pounds of compression force if continued beyond the primary safety limit, This could lead, to patient discomfort or injury. (2) Advisory: Naviscan recommends that patient breast positioning be completed by ceasing motorized-compression when the primary safety limit of 15 pounds pre-compression force is reached. This is indicated by the automatic stopping of the paddle movement as controlled by the primary safety system. "Fine-tuning" positioning, should be completed by using the manual adjustment knobs. (3) Correction: A Naviscan Field Service Engineer will contact each customer to schedule a field correction visit. If customers have any questions they were instructed to contact Naviscan Customer Support at 1-888-628-4159.
Quantity in Commerce 13
Distribution Nationwide to CA, FL, MA, MO, NY, OK, PA, TX, and WA
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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