Z-3277-2011

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

Name: Z-3277-2011 CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & storage...
Creator: Picis Inc.
Published: 2009-08-12
License: https://open.fda.gov/license/

Picis Clinical Solutions, Inc. / initiated 2009-08-12 / Terminated / root cause: software

FDA source

Picis Inc. began a recall of CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & storage, patient data. This product is a non-alarming software... on 2009-08-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3277-2011
Status: Terminated
Initiated: 2009-08-12
Posted: 2011-09-23
Terminated: 2011-09-27
Recalling firm: Picis Clinical Solutions, Inc.
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.
Product code: NSX
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
Root cause tag: software
FDA root cause: 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.
Product codes and lots: S/W version 7.1 release date - February 2004

Product code NSX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)