Visicu, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0399-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 27, 2015

Date Posted: December 16, 2015

Recall Number: Z-0399-2016

Event ID: 70931

Reason for Recall:

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.

Status: Terminated

Product Quantity: 43

Code Information:

eCareManager v3.7, 3.7.1, v3.8, and v3.9

Distribution Pattern:

US distribution only.

Voluntary or Mandated:

Voluntary: Firm initiated