Z-0399-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 16, 2015
- Initiation Date
- March 27, 2015
- Termination Date
- September 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43
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.
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.
Distribution Pattern
US distribution only.
Code Information
eCareManager v3.7, 3.7.1, v3.8, and v3.9