iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image m

FDA device recall Z-0118-2009 · posted 2008-10-28 · Terminated

Recall details

Recalling firm

Philips Healthcare Informatics, Inc.

Reason for recall

Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presentation States and when opening two or more studies from a folder or an exam worklist and 2) potential to miscalculate measurements when Pixel Spacing and Imager Pixel Spacing DICOM tag values are bot

Action taken

A notification letter (Urgent Product Correction) dated 8/29/08 was sent via certified mail to all customers alerting them of the issue, requiring posting of notification. Philips Healthcare Informatics, Inc. strongly recommend all customers advise their iSite Radiology users not to open multiple patient exams simultaneously from a folder or worklist using Conference Presentation States. A software correction is being worked on, and should be available by end of Q3 2008 for version 4.1.45.2. A mandatory upgrade is required for all customers who are currently using iSite version 4.1.45.2 and former versions. For specific questions regarding these issues, contact the Customer Advocate (CARE) or Customer Care at Philips Healthcare Informatics, Inc. at 1-877-328-2808. In your communication with Customer Care at Philips Healthcare Informatics, Inc. , please refer to this notification and associated FCO 22945704-08292008-004.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

27 units.

Distribution

Worldwide Distribution including USA (MN, CO and PA) and countries of Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia.

Date initiated

2008-08-29

Date posted

2008-10-28

Date terminated

2010-11-30

Location

Foster City, CA

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