Z-2236-2020Class II

Giraffe Incubator with installed Servo Oxygen module. Infant incubator

Name: Z-2236-2020 Giraffe Incubator with installed Servo Oxygen module. Infant incubator
Creator: GE Healthcare, LLC
Published: 2020-04-28
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-04-28 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Giraffe Incubator with installed Servo Oxygen module. Infant incubator on 2020-04-28. FDA classified it as Class II and gives the reason as "Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2236-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-28
Posted: 2020-06-15
Terminated: 2024-09-23
Recalling firm: GE Healthcare
Product: Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Product code: FMZ Incubator, Neonatal
Reason for recall: Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.
Root cause tag: design
FDA root cause: Device Design
Action: GE Healthcare notified customers on about 04/28/2020 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that certain Giraffe Incubators and Giraffe OmniBeds manufactured before 2012 can deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed in the device. Instructions included that if the Giraffe Incubator or Giraffe OmniBed device was manufactured before 2012 AND has the oxygen sensor part number M-43GE installed, the Servo Oxygen feature will need to be disabled or the device will have to be taken out of service. Instructions were provided for more information regarding product configurations impacted along with the detailed safety instructions. Step 1. Locate the serial number on the back of your Giraffe Incubator or Giraffe OmniBed. Check the 4th letter of the serial number. If the 4th letter is in the range of R through Z, the device can be used, no further action. If the 4th letter is in the range of A through Q, proceed to step 2. Step 2. Visually check to see if the Servo Oxygen module is installed in your Giraffe Incubator or Giraffe OmniBed. Look under the power cord inlet to see if the metal box and fittings, indicative of the presence of the Servo Oxygen module, are present. If the Servo Oxygen module is NOT installed, the device can be used, no further action. If the Servo Oxygen module is installed, proceed to step 3. Step 3. Determine whether Servo Oxygen software revision needs to be checked: a. If the 4th letter of the bed serial number is in the range from A through M, proceed to step 4. b. If the 4th letter of the bed serial number is in the range of N through Q, turn the device power off and then back on and watch the screen to determine the Servo Oxygen software revision. Note this screen will appear for 3 to 5 seconds. If the software revision identified is 1.60, the device can be use
Quantity in commerce: 5,883 units total
Distribution: Worldwide Distribution. US nationwide including US Virgin Islands, Australia, Austria, Bahrain, Belgium, Bermuda, Bulgaria, Burundi, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Hong Kong, India, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Republic of Korea, Kuwait, Latam, Latvia, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, OMAN, State of Palestine, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen
Product codes and lots: Giraffe Incubator: serial numbers HDGA through HDGQ; Servo Oxygen Board spare part kit: 6600-0233-850; Servo Oxygen upgrade kits: 6600-0678-800, 6600-0678-801, 6600-0678-802, 6600-0678-803, 66000849-800, 6600-0849-801, 6600-0849-802, 6600-0849-803, 6600-0866-800, 6600-0866-801, 6600-0867800, 6600-0867-801, M1142293 or M1142295.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2236-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2235-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-15
Z-2236-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-15

Product code FMZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)