The eCareManager system. Software intended for use in data… recallZ-0399-2016 · Visicu, Inc. · initiated Mar 27, 2015
Class II Terminated All recalls posted in December 2015
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
A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. At the stage where the order is signed, the medication displayed may be incorrect.
FDA root cause category: Software design
What the company is doing
Philips Visicu sent an "Field Safety Notification" to all affected customers still using an affected version of eCareManager. (4 Customers) 03/27/2015 The letter identified the problem and circumstances in which the defect can occur; recommend actions the customer should take to prevent risks for patients; and list the actions planned by Philips to correct the problem. "Philips Hospital to Home has taken corrective action to address the software defect in all supported versions of eCareManager software. Philips Hospital to Home is working with affected customers to complete the necessary upgrade. Please contact your local Philips Representative for further questions.
Recall details
- Recall number
- Z-0399-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 27, 2015
- Posted by the FDA
- Dec 10, 2015
- Recalling firm
- Visicu, Inc.
- Quantity
- 43
- Product code
- MSX
- FDA submissions
- K001972, K012171
- Distribution
- US distribution only.
Product description
The eCareManager system. Software 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. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.
Code information (models, lots, serial numbers)
eCareManager v3.7, 3.7.1, v3.8, and v3.9
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.
How recalls are matched to devices · Editorial policy · Report an error on this page