Recall Z-2738-2018 ยท CBK Ventilator, Continuous, Facility Use
Datex-Ohmeda, Inc.
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.
| Date | Jun 28, 2018 |
| Status | Terminated |
| Reason | The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable. |
| Root cause | Under Investigation by firm |
| Action | The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 6/28/2018 to its customers on 06/28/2018. The letter describes the product, problem and actions to be taken. The customers were instructed to complete and return the attached "Customer Response" for via email to Recall34092.NFSCable@ge.com. The firm requested the return of cables that lacked the connector housing. GE Healthcare will replace all affected products at no cost to you. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your l |
| Quantity | 417 units |
| Distribution | Worldwide Distribution: US (nationwide) to: Washington, DC and countries of: Algeria, Bangladesh, Brazil, Chile, China, Colombia, Germany, Greece, Guatemala, Honduras, India, Indonesia, Iran, Iraq, Italy, Kenya, Lebanon, Malaysia, Maldives, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nigeria, Pa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142679 | CARESCAPE R860 Datex-Ohmeda, Inc., Jun 12, 2015 |