Z-3160-2011

Picis ED PulseCheck-Software, transmission & storage, patient data Service Pack v5.0 L and M This product is...

Name: Z-3160-2011 Picis ED PulseCheck-Software, transmission & storage, patient data Service Pack v5.0 L and M This product is...
Creator: Picis Inc.
Published: 2011-08-01
License: https://open.fda.gov/license/

Picis Clinical Solutions, Inc. / initiated 2011-08-01 / Terminated / root cause: software

FDA source

Picis Inc. began a recall of Picis ED PulseCheck-Software, transmission & storage, patient data Service Pack v5.0 L and M This product is a non-alarming software patient information system... on 2011-08-01. The reason FDA records is "Software does not display appropriate allergy interaction warning". 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-3160-2011
Status: Terminated
Initiated: 2011-08-01
Posted: 2011-09-07
Terminated: 2013-06-27
Recalling firm: Picis Clinical Solutions, Inc.
Product: Picis ED PulseCheck-Software, transmission & storage, patient data Service Pack v5.0 L and M 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: Software does not display appropriate allergy interaction warning
Root cause tag: software
FDA root cause: Software design
Action: Picis issued notification on 08/01/11 to affected clients, explaining the potential for the error, with instructions to monitor documented patient allergies closely when prescribing medication orders in ED PulseCheck, using Muitum drug database content. Picis will track the progress on acknowledgement of notification letter receipt through the implementation of software upgrade, for all potentially affected Customers. For questions regarding this recall call 781-557-3000.
Quantity in commerce: 62
Distribution: Nationwide Distribution
Product codes and lots: Service Pack v5.0 L and M

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)