Company: Philips Healthcare
Date of Enforcement Report 8/5/2009
Class:ll
PRODUCT
Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data collection, storage, and management, Recall # Z-1654-2009
REASON
Error in therapy scheduling: If scheduled orders are documented and edited prior to the orders’ original schedule time, ICIP can create a second instance of the same order marked as pending. A second instance of an order may result in a patient receiving duplicate therapy or patients may not receive their scheduled therapies.
RECALLING FIRM/MANUFACTURER
Philips Healthcare, Inc., Andover, MA, by letters on May 6, 2009 and May 27, 2009. Firm initiated recall is ongoing..
VOLUME OF PRODUCT IN COMMERCE
105 units
DISTRIBUTION
DC, IL, IN, KY, MA, MD, ME, OK, PA, , RI, TX, WV Foreign: Australia, Belgium, China, Denmark, France, Germany, Ireland, Italy, Kenya, Malaysia, Netherlands Singapore, Spain, Switzerland, Taiwan, UAE, UK