Philips Visicu eCareCoordinator Software Error Recall
Philips Visicu is recalling eCareCoordinator software due to an error that prevents patient task reminders from being generated.
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 hazard involves a software error that prevents patient reminders, which is a functional defect but does not involve direct physical injury or high-risk pathogens, fitting the Moderate criteria for low-risk functional issues.
Plain-English summary
Philips Visicu is recalling nine units of the eCareCoordinator software, version 1.3. This medical device software is used by professional medical staff to schedule patient tasks, such as taking weight measurements and blood pressure readings.
The recall is due to a software error in the adherence check function. This error results in two specific issues: no adherence flag is generated for the affected day, and no task is generated for the date 14 days later. Consequently, patients may not receive reminders on their tablets to take required measurements. An error message is generated and forwarded to operations when this occurs.
The affected units were distributed in the United States to the states of Florida, Massachusetts, Michigan, Mississippi, Pennsylvania, and Kansas. The specific code for the affected software is 453564506091.
The recalled product
- Product
- eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
- Manufacturer
- Philips Visicu
- Category
- Medical Device — Software
- Affected units
- 9
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 1.3
Distribution
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