FDA Device recall Z-0399-2016
The eCareManager system
- FDA Device
- Class II
- terminated
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class II recall of The eCareManager system by Visicu, citing 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 functi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0399-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-27 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Visicu |
| Distribution | n/a |
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.
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.
Identifiers
| code_info | eCareManager v3.7, 3.7.1, v3.8, and v3.9 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0399-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.