FDA Medical Device Recalls (openFDA)
Philips Visicu: 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.
- Recall number
- Z-1708-2017
- Recalling firm
- Philips Visicu
- 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.
- Status
- Terminated
- Initiated
- 2017-03-02
- Posted
- not on file
- Terminated
- 2017-10-27
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- Field Safety Notice (FSN) will be sent to all customers using eCareCoordinator all Versions. The FSN describes the problem and circumstances in which the design defects occurs and the action planned by Philips to correct the problem. The FSN will also detail the functionality change in detail. A software correction will be made and released.by the vendor. Customers will have this correction applied to their current version when made available by Vendor in order to fix this correction.
- Quantity
- 26
- Distribution
- Worldwide Distribution-US Nationwide
- Lot, serial or model codes
- 453564506091 eCareCoordinator
- 510(k) numbers
- ["K141706"]
- PMA numbers
- not on file
- Product code
- DRG
- Firm FEI
- 3003063823
- Firm city
- Baltimore
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28