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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