GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic pati
FDA device recall Z-0456-2009 · posted 2008-12-03 · Terminated
Recall details
- Recalling firm
- GE Healthcare Integrated IT Solutions
- Reason for recall
- Software anomalies in the Alert and Reminder feature could result in a delay of treatment. When attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may be displayed for the same clinical element across a set of work stations.
- Action taken
- The software was updated to version 6.80.1 on 4/22/08, however, the consignee was notified of the software defects relating to the last visible Alerts and Reminders choice and the inconsistent display for the same clinical element across a set of work stations, via Product Safety Notification letter dated 8/29/08, sent via first class mail on 9/24/08. If there were any questions, the customer was to contact Tech Support at 1-800-433-2009.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HGM
- Quantity affected
- 1 unit
- Distribution
- Nationwide Distribution --- state of Ohio.
- Date initiated
- 2008-09-25
- Date posted
- 2008-12-03
- Date terminated
- 2008-12-03
- Location
- Barrington, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUANTITATIVE SENTINEL SYSTEM (K993008) | Marquette Medical Systems, Inc. | 1999-12-06 |