Philips eCare Coordinator Software Recalled for Data Integrity Defects
Philips Visicu is recalling eCare Coordinator software due to a defect that may cause missing or redundant data to be saved without user notification.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The defect involves data integrity (missing or redundant data) without explicit reports of patient injury or death, fitting the criteria for moderate severity involving potential harm or significant functional issues.
Plain-English summary
Philips Visicu is recalling 26 units of eCare Coordinator (eCC) software. The software is intended for data aggregation, patient interaction facilitation, storage, and clinical information management with independent physiological devices and ancillary systems. It is designed to provide patient information from the patient location to a remote care team via networking technology. The software is an informational tool only and does not send real-time alarms or provide automated treatment decisions.
A software defect was discovered in the eCare Coordinator Clinical User Interface. This defect can at times cause missing or redundant data to be saved without notification to the user. The recall is distributed worldwide and across the US nationwide.
Healthcare providers using this software should be aware that the data integrity may be compromised. The software is not intended to be used as a substitute for professional judgment in diagnosing and treating patients.
The recalled product
- 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 network
- Manufacturer
- Philips Visicu
- Category
- Medical Device — Software
- Hazard
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 453564506091 eCareCoordinator
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Philips Visicu
See all →- ModeratePhilips Visicu eCareCoordinator Software Error Recall
FDA (Devices) · 2016-05-04
Same hazard · data integrity
See all →- ModerateVentana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies
FDA (Devices) · 2026-08-19
- SevereGE Healthcare MAC VU360 Electrocardiograph Software Recall
FDA (Devices) · 2026-08-12
- SevereCopan WASPLab Software Recall Over Results Overwrite Issue
FDA (Devices) · 2026-08-12
- SevereMedline spinal anesthesia trays recalled over Huons bupivacaine quality concerns
FDA (Devices) · 2026-06-03
- SevereMedline pain and Whitacre spinal trays recalled over bupivacaine concerns
FDA (Devices) · 2026-06-03