FDA Recall Terminated

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.

Recall: Z-3277-2011 · Initiated August 12, 2009

Recall

Recall Number
Z-3277-2011
Event Number
53897
Firm
Picis Inc.
FEI Number
3005244943
Product Code
NSX
Status
Terminated
Root Cause
Software design
Initiated
August 12, 2009
Posted
September 23, 2011
Terminated
September 27, 2011
Address
100 Quannapowitt Parkway, Suite 405, Wakefield, MA, 01880

Description

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.

Reason

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

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.

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.

Quantity

8576 UNITS