GE Healthcare recalls Giraffe OmniBed Carestation CS1 models with fasteners that may become detached, risking falls. Check serial numbers for affected units.
Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
GE Healthcare is recalling Giraffe OmniBed Carestation CS1 devices that may have fasteners torqued incorrectly, potentially causing the canopy to detach and fall. This poses a risk of injury to infants using the device as an incubator or warmer.
The fasteners on the device may be torqued to a value less than specified, which can cause the canopy to become detached. If the canopy falls, it could injure an infant by striking them or causing a fall.
Parents or caregivers of newborns using the Giraffe OmniBed CS1 as an incubator or warmer are most at risk. The device is designed for neonatal care in hospitals and clinics.
Check the serial number (UDI) on the device, which starts with 'TABY' followed by numbers. Affected units have specific serial numbers listed in the recall notice, including TABY70690 through TABY70755 (with some marked 'Not Available').
Look for the serial number on the device, which begins with 'TABY' followed by a 10-digit code. Affected units have specific serial numbers listed in the recall notice.
The fasteners may be torqued to a value less than specified, potentially causing the canopy to detach and fall, which could injure an infant.
Check the serial number on the device, which starts with 'TABY' followed by numbers. Affected units include specific serial numbers listed in the recall notice, such as TABY70690 through TABY70755 (with some marked 'Not Available').
The recall does not specify a remedy, so contact GE Healthcare directly to determine if your device is affected and what steps to take.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0281-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0281-2020 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
