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.
FDA Recall Z-2738-2018 · Posted None
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Recalling FirmDatex-Ohmeda, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2018-06-28
Date Terminated2019-02-22
Product Quantity417 units
Reason for Recall
The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
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 [email protected]. 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 local Service Representative.
Root Cause
Under Investigation by firm
Distribution Pattern
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, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Tunisia, Turkey, United Arab Emirates, and Vietnam.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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