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Terminated

Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1

FDA Recall Z-0479-2019 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeFMZ
Date Initiated2018-09-25
Date Terminated2020-07-13
Product Quantity1,724 devices total

Reason for Recall

Potential electric leakage affecting the user.

Firm Action

GE Healthcare notified customers on about 09/25/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter indicated that the device could continue to be used along with good clinical practices. GE Healthcare will visit each location to perform the necessary testing. Until GE Healthcare can visit each site, instructions are to disconnect devices that use the USB (Giraffe OmniBed Carestation and Giraffe Incubator Carestation only) and the RS232 Nurse call ports, and inspect all power cords to ensure there is no damage to the cord or ground pin. GE Healtchare will perform necessary electrical safety test on all affected products and correct if required. A GE Healthcare representative will contact each customer to arrange for this test. For questions or concerns, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Process design

Distribution Pattern

Worldwide distribution. US Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Honduras, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016-03-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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