Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.
Reported: November 13, 2019 Initiated: July 26, 2019 #Z-0281-2020
Product Description
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.
Reason for Recall
Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 59 devices (50 US, 9 OUS)
- Distribution
- Worldwide distributions - US Nationwide in the states of CA, CT, FL, ID, IL, KS, MI, NC, NC, NJ, NM, PA, TX, VA. Countries of China, France, Germany, Korea, Republic of China.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.. Recalled by GE Healthcare, LLC. Units affected: 59 devices (50 US, 9 OUS).
Why was this product recalled? ▼
Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2019. Severity: Moderate. Recall number: Z-0281-2020.
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