Severe FDA (Devices)·Z-0281-2020·Announced 2019-11-13

GE Healthcare Recalls Giraffe OmniBed Carestation CS1 Due to Fastener Risk

GE Healthcare is recalling 59 Giraffe OmniBed Carestation CS1 devices because fasteners may be under-torqued, posing a risk that the canopy could detach and fall.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device that could cause a canopy to fall, posing a significant injury risk to patients, which aligns with the rubric for structural defects or significant injury reports.

Plain-English summary

GE Healthcare, LLC is recalling 59 units of the Giraffe OmniBed Carestation CS1, a medical device used to provide controlled heat to neonates as either an incubator or a warmer. The recall involves 50 devices in the United States and 9 devices outside the US.

The recall is due to a defect where fasteners may have been torqued to a value less than the specified requirement. This condition can potentially cause the device's canopy to become detached and fall. The affected devices were distributed in the US states of CA, CT, FL, ID, IL, KS, MI, NC, NJ, NM, PA, TX, and VA, as well as in China, France, Germany, Korea, and the Republic of China.

Healthcare facilities should identify affected units by checking the model number 2082844-001 and the specific serial numbers listed in the recall notice. Users should contact GE Healthcare for instructions on how to address the defect.

The recalled product

Product: 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 man
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Neonatal Care
Hazard: falling-object
structural-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model Number: 2082844-001
Serial Number (UDI Number): TABY70690 (010084068211686221TABY7069011190610)
TABY70692 (010084068211686221TABY7069211190611)
TABY70708 (010084068211686221TABY7070811190612)
TABY70719 (010084068211686221TABY7071911190613)
TABY70709 (010084068211686221TABY7070911190612)
TABY70724 (010084068211686221TABY7072411190614)
TABY70722 (010084068211686221TABY7072211190614)
TABY70718 (010084068211686221TABY7064211190603)
TABY70717 (010084068211686221TABY7064411190603)
TABY70712 (010084068211686221TABY7064511190603)
TABY70678 (010084068211686221TABY7067811190607)
TABY70725 (010084068211686221TABY7072511190615)
TABY70672 (010084068211686221TABY7067211190607)
TABY70686 (010084068211686221TABY7068611190610)
TABY70688 (010084068211686221TABY7068811190610)
TABY70697 (010084068211686221TABY7069711190611)
TABY70726 (010084068211686221TABY7072611190616)
TABY70729 (010084068211686221TABY7072911190616)
TABY70645 (010084068211686221TABY7064711190604)

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Same manufacturer · GE Healthcare, LLC

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