Visicu eCareManager Software Recalled for Medication Order Defect
Visicu, Inc. is recalling 43 units of eCareManager software due to a defect that may cause incorrect medication orders to be displayed and signed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical software) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Visicu, Inc. is recalling 43 units of the eCareManager system, a software product intended for data collection, storage, and clinical information management in hospital environments. The affected software versions are v3.7, 3.7.1, v3.8, and v3.9. The recall is limited to US distribution.
The recall is due to a software defect that may cause incorrect medication order changes. If a user edits an order prior to electronic signature and selects the 'return to Previous Screen' function, the previously selected medication may be replaced with the medication in the number one spot on the complete medication list. Consequently, the medication displayed at the stage where the order is signed may be incorrect.
Hospitals using the affected eCareManager software should contact Visicu, Inc. for further instructions on how to address the defect. The source text does not specify a date for the recall or report any illnesses or injuries associated with this defect.
The recalled product
- 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 allo
- Manufacturer
- Visicu, Inc.
- Hazard
- Affected units
- 43
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- eCareManager v3.7
- 3.7.1
- v3.8
- and v3.9
Distribution
Distribution scope not specified by the agency.
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