FDA Medical Device Recalls (openFDA)
GE Healthcare Integrated IT Solutions: 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
- Recall number
- Z-0112-2009
- Recalling firm
- GE Healthcare Integrated IT Solutions
- Product
- 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
- Status
- Terminated
- Initiated
- 2008-09-25
- Posted
- 2008-10-15
- Terminated
- 2010-05-17
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 470 units
- Distribution
- Worldwide Distribution --- including USA and country of Canada.
- Lot, serial or model codes
- software version 6.70.6 of the Centricity Perinatal clinical information system
- 510(k) numbers
- ["K993008"]
- PMA numbers
- not on file
- Product code
- HGM
- Firm FEI
- 3004526608
- Firm city
- Barrington
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28