Z-0365-2010

PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager...

Name: Z-0365-2010 PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager...
Creator: Picis Inc.
Published: 2009-04-08
License: https://open.fda.gov/license/

Picis Clinical Solutions, Inc. / initiated 2009-04-08 / Terminated / root cause: software

FDA source

Picis Inc. began a recall of PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient... on 2009-04-08. The reason FDA records is "Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your "HIS" or "CIS") and certain Picis applications, if...". 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-0365-2010
Status: Terminated
Initiated: 2009-04-08
Posted: 2009-11-18
Terminated: 2014-12-22
Recalling firm: Picis Clinical Solutions, Inc.
Product: PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems.
Product code: NSX
Reason for recall: Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your "HIS" or "CIS") and certain Picis applications, if that interface is not configured properly.
Root cause tag: software
FDA root cause: Software design
Action: On April 8th 2009, Picis initiated a customer notification letter to the installed base of potentially affected users, explaining the potential source of patient data conflict and to provide support in choosing the appropriate configuration option and implementation. The notification letters included with this report package contain additional details regarding configuration options.
Quantity in commerce: 325
Distribution: Worldwide distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom
Product codes and lots: Software version 7.2.2

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)