Class 2 Device Recall Giraffe Infant Warmers

• Date Initiated by Firm: December 12, 2013
• Date Posted: February 03, 2014
• Recall Status: Terminated on June 01, 2015
• Recall Number: Z-0912-2014
• Recall Event ID: 67225
• 510(K)Number: K123309
• Product Classification: Warmer, infant radiant - Product Code FMT
• Product: Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*; ; Giraffe¿ Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
• Code Information: Serial Numbers: HDJR52093 HDJQ52878 HDJS51010 HDJP51983 HDJN52273 HDJN52274 HDJN52275 HDJN52276 HDJP50604 HDJP50605 HDJM50388 HDJR56613 HDJQ52689 HDJR50734 HDJR50735 HDJS50028 HDJP52371 HDJP52558 HDJN51693 HDJN51694 HDJR56618 HDJQ51960 HDJS52390 HDJM50693 HDJM51714 HDJM51716 HDJM51717 HDJM51718 HDJM52096 HDJN52193 HDJN52194 HDJN52195 HDJN52196 HDJN52197 HDJP52562 HDJP52563 HDJP52564 HDJP52565 HDJQ52920 HDJQ52917 HDJQ52918 HDJQ52919 HDJQ52921 HDJQ52922 HDJQ52923 HDJQ52924 HDJQ52925 HDJQ52926 HDJQ52927 HDJQ53075 HDJR56481 HDJR56482 HDJR56486 HDJR56487 HDJR56488 HDJR56489 HDJR56490 HDJR56491 HDJR56358 HDJP50531 HDJP50532 HDJR56107 HDJR56370 HDJR56669 HDJR56746 HDJR56747 HDJR56748 HDJM51930 HDJM52089 HDJM51405 HDJM51470 HDJM51471 HDJM51472 HDJM51475 HDJM51847 HDJS51291 HDJS51292 HDJR54229 HDJQ51474 HDJQ51475 HDJQ51476 HDJM52059 HDJM50272 HDJP50634 HDJQ51827 HDJR50477 HDJR57730 HDJM50483 HDJQ52812 HDJS52096 HDJR57172 HDJM50694 HDJN51776 HDJN51777 HDJN51778 HDJQ51257 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• Recalling Firm/ Manufacturer: GE Healthcare; 8880 Gorman Rd; Laurel MD 20723-5800
• Manufacturer Reason for Recall: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
• FDA Determined Cause: Process control
• Action: GE Healthcare notified end users with a letter flagged as Urgent Medical Device Correction letter on 12/12/2013. The notification advised that GE Healthcare has become aware of a potential safety issue associated with the loosening of the blender knob shaft on all Resuscitation units. The firm advised that accounts ensure that all potential users in their facility are made aware of this safety notification and the recommended actions described in the notification: 1. Perform blender accuracy check as outlined in Section 2.5-2.5.1 of the Service Manual to verify that the O2 concentration set at 21% is within 16-26% O2 and the concentration at 100% setting is within the recommended range (95-105% O2). 2. If the blender accuracy test results do not meet specifications, remove the unit from patient use and contact a GE Healthcare Service Representative at the number listed below. 3. If the blender accuracy check passes in Step 1 above, you may continue to use your resuscitation system. The following precautions are recommended to ensure blender accuracy is maintained between system checks. ¿ Use an independent oxygen analyzer, as determined by your hospital policy, to check blended Air/O2 accuracy. ¿ When delivering Oxygen, use a pulse oximeter to monitor your patient. Customers were requested to contact a GE Healthcare Service Representative at 1-800-345-2700 to arrange for correction if the device is found to be defective.
• Quantity in Commerce: 1970 units
• Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

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.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FMT and Original Applicant = OHMEDA MEDICAL