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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- 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.
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