Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data ma
FDA device recall Z-0112-2009 · posted 2008-10-15 · Terminated
Recall details
- Recalling firm
- GE Healthcare Integrated IT Solutions
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HGM
- Quantity affected
- 470 units
- Distribution
- Worldwide Distribution --- including USA and country of Canada.
- Date initiated
- 2008-09-25
- Date posted
- 2008-10-15
- Date terminated
- 2010-05-17
- 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 |