Z-1708-2017Class II

eCare Coordinator

Name: Z-1708-2017 eCare Coordinator
Creator: Philips Visicu
Published: 2017-03-02
License: https://open.fda.gov/license/

Visicu, Inc. / initiated 2017-03-02 / Terminated / root cause: software

FDA source

Philips Visicu began a recall of eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information... on 2017-03-02. FDA classified it as Class II and gives the reason as "eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are...". 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-1708-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-02
Posted: 2017-04-04
Terminated: 2017-10-27
Recalling firm: Visicu, Inc.
Product: eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCare Coordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.
Product code: DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Reason for recall: eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. A software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Field Safety Notice (FSN) will be sent to all customers using eCareCoordinator all Versions. The FSN describes the problem and circumstances in which the design defects occurs and the action planned by Philips to correct the problem. The FSN will also detail the functionality change in detail. A software correction will be made and released.by the vendor. Customers will have this correction applied to their current version when made available by Vendor in order to fix this correction.
Quantity in commerce: 26
Distribution: Worldwide Distribution-US Nationwide
Product codes and lots: 453564506091 eCareCoordinator

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1708-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1708-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-04

Product code DRG

K141706Class IIEcare Coordinator (Ecc)Visicu, Inc. / cleared 2014-09-09

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)