Recall Z-1557-2016— Philips Visicu
Class II · Terminated
Class II FDA medical device recall by Philips Visicu, initiated 2016-03-10, terminated 2017-10-27. It names one FDA 510(k) clearance: K141706. Product: 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.
- Recalling firm
- Philips Visicu
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-10
- Terminated
- 2017-10-27
- Firm location
- Baltimore, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.