Recall Z-0399-2016— Visicu, Inc.
Class II · Terminated
Class II FDA medical device recall by Visicu, Inc., initiated 2015-03-27, terminated 2016-09-23. It names 2 FDA 510(k) clearances: K012171, K001972. 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..
- Recalling firm
- Visicu, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-27
- Terminated
- 2016-09-23
- Firm location
- Baltimore, MD, United States
510(k) clearances named in this recall
2 on FDA's record- K012171 — MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
- K001972 — ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.