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Terminated

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

FDA Recall Z-1557-2016 · Posted None

Recalling FirmPhilips Visicu
Recall StatusTerminated
Product CodeDRG
Date Initiated2016-03-10
Date Terminated2017-10-27
Product Quantity9

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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