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CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & storage, patient data.

FDA device recall Z-3277-2011 · posted 2011-09-23 · Terminated

Recall details

Recalling firm
Picis Inc.
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
Action taken
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.
Root cause
Software design
Status
Terminated
Product code
NSX
Quantity affected
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
Date initiated
2009-08-12
Date posted
2011-09-23
Date terminated
2011-09-27
Location
Wakefield, MA

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