PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: November 28, 2018 Initiated: September 25, 2018 #Z-0480-2019

Product Description

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

Reason for Recall

Potential electric leakage affecting the user.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
1,724 devices total
Distribution
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.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1. Recalled by GE Healthcare, LLC. Units affected: 1,724 devices total.
Why was this product recalled?
Potential electric leakage affecting the user.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 28, 2018. Severity: Moderate. Recall number: Z-0480-2019.