The eCareManager system. Software intended for use in data collection, storage and clinical information management with
FDA device recall Z-0399-2016 · posted 2015-12-10 · Terminated
Recall details
- Recalling firm
- Visicu, Inc.
- 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.
- Action taken
- Philips Visicu sent an "Field Safety Notification" to all affected customers still using an affected version of eCareManager. (4 Customers) 03/27/2015 The letter identified the problem and circumstances in which the defect can occur; recommend actions the customer should take to prevent risks for patients; and list the actions planned by Philips to correct the problem. "Philips Hospital to Home has taken corrective action to address the software defect in all supported versions of eCareManager software. Philips Hospital to Home is working with affected customers to complete the necessary upgrade. Please contact your local Philips Representative for further questions.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MSX
- Quantity affected
- 43
- Distribution
- US distribution only.
- Date initiated
- 2015-03-27
- Date posted
- 2015-12-10
- Date terminated
- 2016-09-23
- Location
- Baltimore, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS (K012171) | Visicu, Inc. | 2001-07-24 |
| ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK (K001972) | Visicu, Inc. | 2000-10-27 |