Philips eCareManager System, Model 865325, software… recallZ-1474-2012 · Visicu, Inc. · initiated Feb 22, 2012
Terminated All recalls posted in April 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Visicu, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File.
FDA root cause category: Software change control
What the company is doing
Philips notified all affected customers via a preliminary email message advising them of the issue. An URGENT - Field Safety Notice follow-up letter was mailed to all customers on February 22, 2012. This letter identified the affected product, described the problem and circumstances in which it can occur; recommend actions the customer should take to prevent risks for patients, and list the actions planned by Philips to correct the problem. For questions contact Philips eICU Customer Support 877-374-2872.
Recall details
- Recall number
- Z-1474-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 22, 2012
- Posted by the FDA
- Apr 27, 2012
- Recalling firm
- Visicu, Inc.
- Quantity
- 12
- Product code
- MSX
- FDA submissions
- K001972, K012171
- Distribution
- Nationwide Distribution (USA) including states of MA, MO, WI, AR, AZ, PA, SD, VA, and IN.
Product description
Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinical information management with independent bedside devices and ancillary systems that are connected either directly or through networks. The eCareManager system provides patient information and surveillance of monitored patients at the point of care location and at a remote, supplementary care location through wide area networking technology and dedicated phone lines and is solely intended for use in a hospital environment. It is not intended to be used in a home environment.
Code information (models, lots, serial numbers)
v3.7, v3.7.1, v3.8
Other devices under the same FDA submission
1 device cleared under K001972, K012171 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- eCareManager 4.1Visicu, Inc. · System,Network And Communication,Physiological Monitors1 death1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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