Device product
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Z-2235-2020
Product summary
- Event
- Event 85643
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,883 units total
- Official record key
device-enforcement:Z-2235-2020
Official wording
Reason: 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.
Code information: Giraffe Incubator: serial numbers HDHA through HDHQ; 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.
Distribution pattern: 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
Derived failure modes
-
Unknown
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.