Recall Z-1474-2012 ยท MSX System, Network And Communication, Physiological Monitors
Visicu, Inc.
Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is 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. The eCareManager system provides patient information and surveil
| Date | Apr 27, 2012 (initiated Feb 22, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software change control |
| Action | 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. |
| Quantity | 12 |
| Distribution | Nationwide Distribution (USA) including states of MA, MO, WI, AR, AZ, PA, SD, VA, and IN. |
| FDA record | Open on fda.gov |