FDA Device recall Z-1708-2017
eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical i…
- FDA Device
- Class II
- terminated
- Published 2017-04-12
On 2017-04-12 the FDA classified a Class II recall of eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical i… by Philips Visicu, citing eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological device….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1708-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-02 |
| Published | 2017-04-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Visicu |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | 453564506091 eCareCoordinator |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1708-2017%22
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