Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010
This recall has been terminated (originally issued October 15, 2008).
- Recall Initiated
- September 25, 2008
- Posted
- October 15, 2008
- Terminated
- May 17, 2010
- Recall Number
- Z-0112-2009
- Quantity
- 470 units
- Firm Location
- Barrington, IL
- Official Source
- View on FDA website ↗
Reason for Recall
On the I&O chart, the IN, OUT and NET fluid totals values will not honor the numeric precision configuration, always displaying a whole number, losing decimal point accuracy.
Distribution
Worldwide Distribution --- including USA and country of Canada.
Lot / Code Info
software version 6.70.6 of the Centricity Perinatal clinical information system
Root Cause
Software design
Action Taken
GE Healthcare notified their Centricity Perinatal customers via letter dated 4/20/07 of the problem with the Fluid I & O Module when fluid precision is required. The letter instructed those accounts that require fluid precision to contact GE Technical Support at 1-800-433-2009 to obtain a software patch to fix the problem. A follow-up letter dated 8/29/08 was sent on the same date to the accounts informing them that GE had re-classified the issue as a class II safety issue and that all customers need to have their software updated. The accounts were requested to contact GE Tech Support at 800-433-2009 to schedule a time to upgrade their system to 6.70.6 P02 as soon as possible. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 847-277-5240.