The Recall Desk
HighFDA (Devices)·Z-0479-2019·Announced 2018-11-28

GE Healthcare Recalls Giraffe OmniBed Neonatal Incubators Due to Electric Leakage

GE Healthcare is recalling 1,724 Giraffe OmniBed Carestation neonatal incubators worldwide due to a potential electric leakage hazard that could affect users.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential electric leakage (shock risk) for a medical device used in a critical care setting. No injuries or deaths are reported in the source text, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 1,724 units of the Giraffe OmniBed Carestation, a neonatal incubator sold under the product names Carestation and Carestation CS1. The recall is being conducted because of a potential electric leakage issue that could affect the user.

The affected devices were distributed worldwide, including in the United States and numerous international markets. The source text does not specify the exact number of devices distributed in the US or other specific regions, nor does it provide a list of specific hospital names.

Consumers and healthcare facilities should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a device is affected, users should follow the instructions provided by GE Healthcare for repair or replacement to mitigate the electric leakage risk.

The recalled product

Product
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Neonatal Incubator
Hazard
Affected units
1,724

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
  • UDI (Serial Number): 2082844-001-526493
  • 010084068211686221TABX6226911180201 (TABX62269)
  • 2082844-001-526493
  • 010084068211686221TABX6215911180122 (TABX62159)
  • 010084068211686221TABX6219811180129 (TABX62198)
  • 010084068211686221TABX6227011180201 (TABX62270)
  • 010084068211686221TABX6229111180202 (TABX62291)
  • 010084068211686221TABX6215611180122 (TABX62156)
  • 010084068211686221TABX6226011180201 (TABX62260)
  • 010084068211686221TABX6213511180119 (TABX62135)
  • 010084068211686221TABX6218911180124 (TABX62189)
  • 010084068211686221TABX6219611180124 (TABX62196)
  • 010084068211686221TABX6218811180124 (TABX62188)
  • 010084068211686221TABX6216011180122 (TABX62160)
  • 2082844-001-487119
  • To be provided (TABV60550)
  • 010084068211686221TABW6398711171213 (TABW63987)
  • 010084068211686221TABX6214111180119 (TABX62141)
  • 010084068211686221TABW6409911171219 (TABW64099)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

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