Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery sy
FDA device recall Z-0337-2014 · posted 2013-11-18 · Terminated
Recall details
- Recalling firm
- GE Healthcare It
- Reason for recall
- 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to review or edit form and chart information. This could result in a potential delay of care; however active fetal strips and permanent patient data storage are not affected. 2) When
- Action taken
- GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 11, 2013, to all affected customers. The letters requested that direct accounts ensure that all potential users of the software were made aware of the potential problems and the recommended actions. Direct accounts were asked to return a customer response form and to return it to GE Healthcare via fax at 847-939-1522 or e-mail at QARAFMl1@ge.com. Version 6.94 of the software has been modified to correct these defects. GE Technical Support: 800-433-2009.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HGM
- Quantity affected
- 1,132 units
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Denmark, Germany, Hong Kong, Korea, South Korea, Thailand and United Kingdom.
- Date initiated
- 2013-03-11
- Date posted
- 2013-11-18
- Date terminated
- 2016-06-10
- Location
- Barrington, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE (K111614) | Ge Healthcare Integrated IT Solutions | 2011-09-26 |