Z-1708-2017 Class II Terminated
FDA device recall Z-1708-2017 was initiated by Philips Visicu on March 2, 2017 and is designated Class II. Reason for recall: eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary syst… The recall status is terminated (terminated October 27, 2017). Affected quantity: 26.
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2017
- Initiation Date
- March 2, 2017
- Termination Date
- October 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26
Product Description
eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCare Coordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.
Reason for Recall
eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. A software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user.
Distribution Pattern
Worldwide Distribution-US Nationwide
Code Information
453564506091 eCareCoordinator