The eCareManager system. Software intended for use in recall: Software Issue
The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices…
Why was The eCareManager system. Software intended for use in 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
eCareManager v3.7, 3.7.1, v3.8, and v3.9
- Product
- The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices…
- Recalling firm
- Visicu, Inc.
- Quantity
- 43
- Distribution
- US distribution only.
- Recall date
- December 16, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)