Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Th

FDA device recall Z-0206-2013 · posted 2012-11-05 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland), Inc.

Reason for recall

Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.

Action taken

The firm, Philips Healthcare, sent a "Customer Information Letter" dated 2012 Oct 05. The letter listed the affected products, problem description, how to identify affected products, advise on actions by customer / user, actions planned by Philips and further information and support. The letter stated that no action is needed on the part of the customer. The field service engineer will be scheduling a site visit to complete the replacement. Philips Healthcare will be delivering the correct VCC kit. For customers in North America if you need any further information or support concerning this issue, please contact our Customer Care Solutions Center at 1-800-722-9377. Select option 5 for "All Imaging Systems". Enter your site ID # (If you do not have a site ID#, simply pause for a moment.). Select option 5 for "Nuclear Medicine" and finally select option 3 for "Pinnacle" support.

Root cause

Process control

Status

Terminated

Product code

IYE

Quantity affected

11

Distribution

Nationwide distribution: USA including states of: ME, MI, NY, and WI.

Date initiated

2012-10-05

Date posted

2012-11-05

Date terminated

2013-02-21

Location

Fitchburg, WI

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