Company:Philips Healthcare Inc.
Date of Enforcement Report 5/18/2011
Class ll:

PRODUCT
Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link. Recall # Z-2175-2011

REASON
Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter on March 16, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
387 units

DISTRIBUTION
Nationwide and Internationally