The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0480-2019·Announced 2018-11-28

GE Healthcare Recalls Giraffe Incubator Carestations Due to Electric Leakage

GE Healthcare is recalling 1,724 Giraffe Incubator Carestations worldwide due to a potential electric leakage hazard that could affect users.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a medical device with a potential electric leakage hazard. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

GE Healthcare, LLC is recalling 1,724 units of the Giraffe Incubator 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 may 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 dates of distribution or the specific model numbers involved beyond the general product description.

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

The recalled product

Product
Giraffe Incubator 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): 2082844-002-527348
  • 010084068211685521TAAW6317711171213 (TAAW63177)
  • 2082844-002-527348
  • 010084068211685521TAAW6317911171213 (TAAW63179)
  • 010084068211685521TAAW6318111171213 (TAAW63181)
  • 010084068211685521TAAX6208911180129 (TAAX62089)
  • 010084068211685521TAAX6208811180124 (TAAX62088)
  • 010084068211685521TAAX6208211180124 (TAAX62082)
  • 010084068211685521TAAW6318011171213 (TAAW63180)
  • 010084068211685521TAAW6317811171213 (TAAW63178)
  • 010084068211685521TAAW6320511171221 (TAAW63205)
  • 010084068211685521TAAW6320611171222 (TAAW63206)
  • 2082844-002-527555
  • 010084068211685521TAAW6317611171212 (TAAW63176)
  • 010084068211685521TAAX6207811180124 (TAAX62078)
  • 010084068211685521TAAX6207911180124 (TAAX62079)
  • 2082844-002-527238
  • 010084068211685521TAAW6317411171212 (TAAW63174)
  • 010084068211685521TAAW6318411171221 (TAAW63184)

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 →

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