Z-0139-2012

Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software...

Name: Z-0139-2012 Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software...
Creator: Picis Inc.
Published: 2011-08-12
License: https://open.fda.gov/license/

Picis Clinical Solutions, Inc. / initiated 2011-08-12 / Terminated / root cause: software

FDA source

Picis Inc. began a recall of Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software, transmission & storage, patient data) This product is a... on 2011-08-12. The reason FDA records is "Periop/Critical Care Manager EHR Software Application displayed one patient's demographic and health information in place of another patient that was in current view". 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-0139-2012
Status: Terminated
Initiated: 2011-08-12
Posted: 2011-10-31
Terminated: 2012-03-23
Recalling firm: Picis Clinical Solutions, Inc.
Product: Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (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: Periop/Critical Care Manager EHR Software Application displayed one patient's demographic and health information in place of another patient that was in current view.
Root cause tag: software
FDA root cause: Software design
Action: Picis Inc. sent a "Safety Notification letter" dated August 12, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed until this service pack is applied, we recommend: * For patients who have been transferred from other facilities within the same VISN, you should discontinue the use of these Picis applications. Manually check the patient's name with that displayed in the Picis patient blue banner to ensure you catch all of these cases. * For all other patients, you may safely continue the use of these Picis applications. For further questions please call (781) 557-3000.
Quantity in commerce: 10
Distribution: Nationwide Distribution -- AZ, DE, FL, IL, NY, OH, PA, WI and WV.
Product codes and lots: 8.2 Service Pack 4 or higher.

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)