FDA · Medical device recall

Giraffe OmniBed with installed Servo Oxygen module… and 1 more product

June 24, 2020 Class II

Date: June 24, 2020
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): 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)
Status: Terminated
Filed by: GE Healthcare, LLC
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.
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

2 products in this recall

Giraffe OmniBed with installed Servo Oxygen module…

Product: Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Quantity: 5,883 units total
Codes and lots: 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.
Recall started: April 28, 2020
Device type: Incubator, Neonatal
Root cause (FDA): Device Design
What the company told customers: 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
Recall number: Z-2235-2020

Giraffe Incubator with installed Servo Oxygen module…

Product: Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Quantity: 5,883 units total
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.
Recall started: April 28, 2020
Device type: Incubator, Neonatal
Root cause (FDA): Device Design
What the company told customers: 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
Recall number: Z-2236-2020

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-2235-2020, Z-2236-2020. The agency record governs; check it and the company before acting.

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