FDA Recall Terminated

eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.

Recall: Z-1557-2016 · Initiated March 10, 2016

Recall

Recall Number
Z-1557-2016
Event Number
73673
Firm
Philips Visicu
FEI Number
3003063823
Product Code
DRG
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
March 10, 2016
Terminated
October 27, 2017
Address
217 E Redwood St, Ste 1900, Baltimore, MD, 21202-3315

Description

eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.

Reason

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

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.

Distribution

US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.

Quantity

9