Recall Z-2229-2008 ยท KPS System, Tomography, Computed, Emission
Naviscan PET Systems
Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology.
| Date | Sep 11, 2008 (initiated Jun 19, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 autom |
| Quantity | 13 |
| Distribution | Nationwide to CA, FL, MA, MO, NY, OK, PA, TX, and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032063 | PEM 2400 PET SCANNER Pem Technologies, Aug 18, 2003 |