Giraffe Incubator Carestation CS1

• • Completed Z-0141-2025 FDA Class I ·initiated 6 Jun 2023

  Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.

• • Terminated Z-0540-2020 FDA Class I ·initiated 11 Oct 2019 ·on shared 510(k) K152809

  Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

• • Terminated Z-0480-2019 FDA Class II ·initiated 25 Sep 2018

  Potential electric leakage affecting the user.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K152809 ↗

FDA Product Code

FMZ

Device Class

Class II

Regulation

21 CFR Part 880.5400

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Giraffe and Panda Warmers

  Class II

  FDA 510(k) K122267 Active Cleared 2 Oct 2012

• Giraffe OmniBed Carestation CS1 Open recall

  Class II

  FDA 510(k) K152814 Active Cleared 17 Mar 2016

• Giraffe and Panda Warmers

  Class II

  CE/MDR FDA 510(k) K101804 Active Cleared 21 Jul 2010