Recall Z-1557-2016 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Philips Visicu
eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
| Date | Mar 10, 2016 |
| Status | Terminated |
| 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 |
| 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 | 9 |
| Distribution | US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141706 | ECARE COORDINATOR (ECC) Visicu, Inc., Sep 9, 2014 |