Company:Picis Inc
Date of Enforcement Report 4/15//2010
Class:ll

PRODUCT
CareSuite” – Critical Care Manager, PACU Manager and Anesthesia Manager Software. Recall # Z-1252-2010

REASON
Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic update status.

RECALLING FIRM/MANUFACTURER
Picis, Inc., Wakefield, MA, by letter beginning on March 8, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
29 units

DISTRIBUTION
NJ, Canada, Australia, Austria, Denmark, Finland, Germany Norway, Portugal, Sweden, France, Netherlands, Spain