Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with o

FDA device recall Z-2229-2008 · posted 2008-09-11 · Terminated

Recall details

Recalling firm

Naviscan PET Systems

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KPS

Quantity affected

13

Distribution

Nationwide to CA, FL, MA, MO, NY, OK, PA, TX, and WA

Date initiated

2008-06-19

Date posted

2008-09-11

Date terminated

2009-03-13

Location

San Diego, CA

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