Z-1557-2016Class II

eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood...

Name: Z-1557-2016 eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood...
Creator: Philips Visicu
Published: 2016-03-10
License: https://open.fda.gov/license/

Visicu, Inc. / initiated 2016-03-10 / Terminated / root cause: software

FDA source

Philips Visicu began a recall of eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical... on 2016-03-10. FDA classified it as Class II and gives the reason as "The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14 days later. An error message is...". 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-1557-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-10
Posted: 2016-04-22
Terminated: 2017-10-27
Recalling firm: Visicu, Inc.
Product: eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
Product code: DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Reason for recall: The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14 days later. An error message is generated and forwarded to operations. Subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement. If the pa
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: 1. Field Safety Notice(FSN) will be sent to all customers using eCareCoordinator v.1.3 platform. The FSN describes the problem and the circumstances in which the design defects occur and the action planned by Philips to correct the problem. The FSN will also detail the functionality change in detail. 2. A software correction will be made and released. Customers will be upgraded to eCC v.1.4. The v.1.4 is scheduled to be released on or about 8 March 2016. The defect will have been corrected and tested.
Quantity in commerce: 9
Distribution: US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.
Product codes and lots: 453564506091 eCareCoordinator 1.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1557-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1557-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-22

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)