Recall Z-0337-2014 ยท HGM System, Monitoring, Perinatal
GE Healthcare It
Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electro
| Date | Nov 18, 2013 (initiated Mar 11, 2013) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111614 | CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE Ge Healthcare Integrated IT Solutions, Sep 26, 2011 |