Z-1474-2012

Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8

Name: Z-1474-2012 Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8
Creator: Visicu, Inc.
Published: 2012-02-22
License: https://open.fda.gov/license/

Visicu, Inc. / initiated 2012-02-22 / Terminated / root cause: software

FDA source

Visicu, Inc. began a recall of Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in... on 2012-02-22. The reason FDA records is "Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File". 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-1474-2012
Status: Terminated
Initiated: 2012-02-22
Posted: 2012-04-27
Terminated: 2012-07-06
Recalling firm: Visicu, Inc.
Product: Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinical information management with independent bedside devices and ancillary systems that are connected either directly or through networks. The eCareManager system provides patient information and surveillance of monitored patients at the point of care location and at a remote, supplementary care location through wide area networking technology and dedicated phone lines and is solely intended for use in a hospital environment. It is not intended to be used in a home environment.
Product code: MSX System, Network And Communication, Physiological Monitors
Reason for recall: Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File.
Root cause tag: software
FDA root cause: Software change control
Action: Philips notified all affected customers via a preliminary email message advising them of the issue. An URGENT - Field Safety Notice follow-up letter was mailed to all customers on February 22, 2012. This letter identified the affected product, described the problem and circumstances in which it can occur; recommend actions the customer should take to prevent risks for patients, and list the actions planned by Philips to correct the problem. For questions contact Philips eICU Customer Support 877-374-2872.
Quantity in commerce: 12
Distribution: Nationwide Distribution (USA) including states of MA, MO, WI, AR, AZ, PA, SD, VA, and IN.
Product codes and lots: v3.7, v3.7.1, v3.8

Product code MSX

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)