FDAFDA · Food and drugs·Recall number Z-1557-2016
eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
Published May 4, 2016 · Recall initiated: March 10, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Visicu
- Distributor
- US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.
- Lot
- 453564506091 eCareCoordinator 1.3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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