IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-clien

FDA device recall Z-1987-2012 · posted 2012-07-11 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time Insensitive" methods.

Action taken

Philips Healthcare sent a Urgent Medical Device Correction letter dated May 31, 2012, to all affected customers. The letter was sent via certified mail to each customer. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. For any further information or support, customers can contact their local Philips representative or local Philips Healthcare office at (1-800-722-9377 Option 5 : Entersite ID or follow the prompts). Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. The user was informed that a field service representative will visit the facility to install the new software. Philips apologizes for any inconveniences caused by this problem.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

38

Distribution

Worldwide Distribution -- Nationwide Distribution including the states of AZ, OR, PA and TX and the countries of Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel

Date initiated

2012-05-23

Date posted

2012-07-11

Date terminated

2013-09-30

Location

Cleveland, OH

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