FDA Medical Device Recalls (openFDA)
Visicu, Inc.: 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.
- Recall number
- Z-0399-2016
- Recalling firm
- Visicu, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2015-03-27
- Posted
- 2015-12-10
- Terminated
- 2016-09-23
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 43
- Distribution
- US distribution only.
- Lot, serial or model codes
- eCareManager v3.7, 3.7.1, v3.8, and v3.9
- 510(k) numbers
- K001972, K012171
- PMA numbers
- not on file
- Product code
- MSX
- Firm FEI
- 3003063823
- Firm city
- Baltimore
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06