Z-0399-2016Class II

The eCareManager system. Software intended for use in data collection, storage and clinical information...

Name: Z-0399-2016 The eCareManager system. Software intended for use in data collection, storage and clinical information...
Creator: Visicu, Inc.
Published: 2015-03-27
License: https://open.fda.gov/license/

Visicu, Inc. / initiated 2015-03-27 / Terminated / root cause: software

FDA source

Visicu, Inc. began a recall of The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and... on 2015-03-27. FDA classified it as Class II and gives the reason as "A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication...". 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-0399-2016
Classification: Class II
Status: Terminated
Initiated: 2015-03-27
Posted: 2015-12-10
Terminated: 2016-09-23
Recalling firm: Visicu, Inc.
Product: The eCareManager system. Software 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. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.
Product code: MSX System, Network And Communication, Physiological Monitors
Reason for recall: A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. At the stage where the order is signed, the medication displayed may be incorrect.
Root cause tag: software
FDA root cause: Software design
Action: Philips Visicu sent an "Field Safety Notification" to all affected customers still using an affected version of eCareManager. (4 Customers) 03/27/2015 The letter identified the problem and circumstances in which the defect can occur; recommend actions the customer should take to prevent risks for patients; and list the actions planned by Philips to correct the problem. "Philips Hospital to Home has taken corrective action to address the software defect in all supported versions of eCareManager software. Philips Hospital to Home is working with affected customers to complete the necessary upgrade. Please contact your local Philips Representative for further questions.
Quantity in commerce: 43
Distribution: US distribution only.
Product codes and lots: eCareManager v3.7, 3.7.1, v3.8, and v3.9

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0399-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0399-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-10

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)