Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.

FDA device recall Z-1312-2014 · posted 2014-03-31 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland), Inc.

Reason for recall

Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013.

Action taken

Philips Healthcare sent an Urgent Field Safety Notice dated February 10, 2014, to all affected consignees. The letter included the Problem Description, Hazard Involved, How to Identify Affected Products, Action to be taken by Customer /User, Actions Planned by Philips and Further Information and Support. Consignees were instructed to review the following information with all members of their staff who need to be aware of the contents of this communication including clinics within their institution that are remotely connected to their Pinnacle Server. Customers were questions were instructed to contact their Philips representative. For customers in North America please contact Customer Care Solutions Center at 1-800-722-9377. For all other countries their local Philips Healthcare Office should be contacted. For questions regarding this recall call 1-800-722-9377.

Root cause

Software design

Status

Terminated

Product code

MUJ

Quantity affected

1016

Distribution

Worldwide Distribution - USA including US: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, S

Date initiated

2014-02-11

Date posted

2014-03-31

Date terminated

2014-11-21

Location

Fitchburg, WI

Related 510(k) clearances