Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager
FDA device recall Z-1474-2012 · posted 2012-04-27 · Terminated
Recall details
- Recalling firm
- Visicu, Inc.
- Reason for recall
- Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File.
- Action taken
- Philips notified all affected customers via a preliminary email message advising them of the issue. An URGENT - Field Safety Notice follow-up letter was mailed to all customers on February 22, 2012. This letter identified the affected product, described the problem and circumstances in which it can occur; recommend actions the customer should take to prevent risks for patients, and list the actions planned by Philips to correct the problem. For questions contact Philips eICU Customer Support 877-374-2872.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- MSX
- Quantity affected
- 12
- Distribution
- Nationwide Distribution (USA) including states of MA, MO, WI, AR, AZ, PA, SD, VA, and IN.
- Date initiated
- 2012-02-22
- Date posted
- 2012-04-27
- Date terminated
- 2012-07-06
- Location
- Baltimore, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |