Z-1557-2016 Class II Terminated
FDA device recall Z-1557-2016 was initiated by Philips Visicu on March 10, 2016 and is designated Class II. 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.… The recall status is terminated (terminated October 27, 2017). Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2016
- Initiation Date
- March 10, 2016
- Termination Date
- October 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
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
Distribution Pattern
US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.
Code Information
453564506091 eCareCoordinator 1.3