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Recall Observatory FDA recall evidence

Device product

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

Z-1557-2016

March 10, 2016

Class II

Product summary

Firm
Philips Visicu
Event
Event 73673
Status
Terminated
Classification
Class II
Quantity
9
Official record key
device-enforcement:Z-1557-2016

Official wording

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

Code information: 453564506091 eCareCoordinator 1.3

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software error. Two issues occur as a result of the software error