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Class 2 Device Recall Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. |
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| Date Initiated by Firm |
April 28, 2020 |
| Create Date |
June 15, 2020 |
| Recall Status1 |
Completed |
| Recall Number |
Z-2236-2020 |
| Recall Event ID |
85643 |
| 510(K)Number |
K993407 K010222 K020547 K101778
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| Product Classification |
Incubator, neonatal - Product Code FMZ
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| Product |
Giraffe Incubator with installed Servo Oxygen module. Infant incubator. |
| Code Information |
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. |
Recalling Firm/
Manufacturer |
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
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| For Additional Information Contact |
800-437-1171
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Manufacturer 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.
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FDA Determined
Cause 2 |
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 |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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| 510(K) Database |
510(K)s with Product Code = FMZ and Original Applicant = OHMEDA MEDICAL
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