Z-1252-2010

CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later

Name: Z-1252-2010 CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later
Creator: Picis Inc.
Published: 2010-03-08
License: https://open.fda.gov/license/

Picis Clinical Solutions, Inc. / initiated 2010-03-08 / Terminated / root cause: software

FDA source

Picis Inc. began a recall of CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later on 2010-03-08. The reason FDA records is "Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic update...". 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-1252-2010
Status: Terminated
Initiated: 2010-03-08
Posted: 2010-04-06
Terminated: 2013-07-01
Recalling firm: Picis Clinical Solutions, Inc.
Product: CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later
Product code: NSX
Reason for recall: Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic update status. At this point, the order documentation becomes frozen at the last dose and/or rate and the user is unable to modify, stop or delete it. This error could impact the fluid bala
Root cause tag: software
FDA root cause: Software design
Action: Picis issued letter notification beginning on March 8, 2010 with software correction information. The letter communicates details of the problem, along with recommendations for mitigating the potential to experience this error condition. Use of the product should be discontinued until the update described in the letter is performed. Customers with questions should call the company at 781-557-3000.
Quantity in commerce: 23
Distribution: NJ Canada, Australia, Austria,Denmark, Finland, Germany Norway,Portugal, Sweden, France,Netherlands, Spain.
Product codes and lots: Software version CareSuite 5.1 and later.

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)