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U.S. Department of Health and Human Services

Class 2 Device Recall CareSuite" Critical Care Manager, PACU Manager and Anesthesia Manager

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 Class 2 Recall
CareSuite" Critical Care Manager, PACU Manager and Anesthesia Manager
see related information
Date Posted September 23, 2011
Recall Status1 Terminated on September 27, 2011
Recall Number Z-3277-2011
Recall Event ID 53897
Product Classification Software, Transmission And Storage, Patient Data - Product Code NSX
Product CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & storage, patient data. This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
Code Information S/W version 7.1 release date - February 2004
Recalling Firm/
Manufacturer
Picis Inc.
100 Quannapowitt Parkway
Suite 405
Wakefield, Massachusetts 01880
Manufacturer Reason
for Recall
Electronic health record software applications malfunctioned in a manner which failed to display the discontinued status for medication orders, as entered by the attending physician
FDA Determined
Cause 2
DESIGN: Software Design
Action Picis Inc. sent a customer notification letter dated August 11, 2009 to all affected customers. The letter describes the product, problem, and action to be taken. Customers informed of the potential patient safety error were advised to make the appropriate configuration change, within current software versions 7.1.4 or later. Contact your local Picis support representative for questions regarding this notice.
Quantity in Commerce 8576 UNITS
Distribution Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Brussels, Belgium, Denmark, Finland, France, Germany, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and UK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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