Company:Picis, Inc.
Date of Enforcement Report 12/9/2009
Class:ll
PRODUCT
PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems. Recall # Z-0365-2010
REASON
Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your “HIS” or “CIS”) and certain Picis applications, if that interface is not configured properly.
RECALLING FIRM/MANUFACTURER
Picis Inc., Wakefield, MA, by letter on April 8th 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
325 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom
