Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, N

FDA device recall Z-1102-2013 · posted 2013-04-12 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Philips was informed that when loading a study to an analysis application while using URL PACS integration configuration, after another study was opened by a review application, the Analysis monitor is updated with the study of the current patient, but the Review monitor conti

Action taken

Philips sent a Urgent Medical Device Correction letter dated February 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They advised their customers that when reviewing two disparate image datasets, not to only be focused on the actual image content but to also be alerted to the patient's study name and/or ID prior to interpretation. They recommend to manually exit the Review and Analysis applications before loading a new study to Intellispace Portal v4.0.2 from the PACS. For North America and Canada contact the Customer Care Solutions Center at (1-800) 722-9377.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

313 units

Distribution

Worldwide Distribution - (USA) Nationwide Distribution including the states of AL, AR, AZ, CA, FL, GA, IA, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI & WV. and the countries of Aus

Date initiated

2013-02-12

Date posted

2013-04-12

Date terminated

2013-11-04

Location

Cleveland, OH