Class 2 Device Recall Upgrade Kit, Resuscitation, TPiece

• Date Initiated by Firm: December 12, 2013
• Date Posted: February 03, 2014
• Recall Status: Terminated on June 01, 2015
• Recall Number: Z-0917-2014
• Recall Event ID: 67225
• 510(K)Number: K070210
• Product Classification: Ventilator, emergency, powered (resuscitator) - Product Code BTL
• Product: Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com***; ; Provides the basic equipment required for pulmonary resuscitation of infants.
• Code Information: Serial Numbers: 100341 100342 100348 200118 200143 200513 200522 200590 200598 200617 201111 201375 201384 201409 201424 201567 201621 201622 201625 201627 201814 202013 202021 202141 202143 202147 202280 202300 202365 202395 202439 202538 203117 203186 203419 203448 203452 203453 203755 203961 204048 204153 204154 204166 204170 204323 204333 204732 204848 204858 204882 204888 204896 204898 204904 204906 204908 205060 205062 205074 205076 205077 205078 205079 205095 205096 205098 205101 205105 205106 205110 205114 205115 205118 205121 205124 205129 205131 205132 205133 205134 205135 205136 205137 205139 205140 205141 205142 205143 205144 205145 205146 205147 205148 205150 205151 205152 205164 205169 205233 205238 205239 205285 205324 205326 205328 205331 205341 205355 205380 205461 205475 205481 205531 205547 205557 205561 205628 205629 205630 205632 205635 205699 205832 205836 205848 205849 205850 205856 205861 205863 205866 205875 205922 205925 205939 205942 205944 205949 205952 205961 205990 206006 206026 206033 206035 206036 206059 206068 206101 206105 206116 206118 206123 206124 206126 206128 206129 206130 206135 206144 206153 206158 206160 206165 206180 206183 206203 206206 206208 206210 206236 206239 206248 206250 206255 206259 206278 206279 206282 206293 206304 206312 206313 206314 206315 206317 206318 206319 206320 206322 206323 206324 206327 206328 206329 206330 206331 206332 206334 206335 206337 206341 206343 206357 206379 206380 206381 206382 206383 206385 206386 206387 206388 206389 206390 206391 206392 206393 206395 206396 206399 206400 206403 206408 206412 206420 206422 206425 206428 206430 206457 206463 206476 206512 206519 206523 206579 206581 206624 206634 206636 206639 206640 206641 206642 206645 206648 206650 206651 206652 206653 206656 206658 206659 206660 206661 206662 206665 206666 206669 206670 206679 206682 206685 206687 206693 206827 206944 206955 206961 206966 207025 207031 207034 207277 207278 207279 207280 207281 207287 207289 207385 207386 207395 207403 207405 207409 207412 207417 207419 207431 207437 207440 207445 207446 207447 207448 207454 207456 207458 207459 207460 207462 207463 207466 207468 207469 207470 207472 207473 207475 207476 207481 207482 207483 207485 207486 207516 207524 207526 207535 207539 207540 207542 207543 207544 207550 207551 207552 207559 207676 207771 207773 207778 207779 207781 207784 207785 207788 207789 207791 207792 207793 207794 207795 207839 207842 207857 207858 207859 207872 207877 207878 207882 207883 207888 207891 207893 207894 207895 207897 207905 207920 207946 208088 208113 208119 208120 208121 208122 208129 208130 208131 208133 208135 208149 208157 208158 208161 208163 208167 208168 208173 208184 208205 208216 208224 208358 208365 208371 208372 208377 208378 208379 208381 208382 208383 208384 208385 208386 208387 208388 208389 208390 208391 208394 208396 208441 208449 208451 208456 208460 208464 208466 208470 208472 208475 208480 208484 208485 208487 208488 208490 208491 208493 208542 208543 208545 208549 208550 208552 208554 208558 208561 208563 208586 208589 208590 208596 208597 208598 208600 208601 208602 208603 208607 208608 208609 208610 208613 208667 208673 208677 208682 208683 208685 208687 208690 208694 208699 208712 208713 208714 208715 208716 208723 208725 208726 208727 208728 208729 208732 208734 208736 208738 208740 208742 208743 208750 208751 208753 208755 208757 208783 208784 208785 208786 208787 208788 208793 208795 208798 208801 208805 208808 208810 208812 208813 208815 208816 208817 208818 208819 208820 208822 208823 208825 208826 208827 208834 208838 208839 208841 208856 208857 208859 208860 208861 208862 208864 208920 209000 209002 209013 209088 209095 209097 209098 209215 209216 209225 209226 209236 209359 209383 209391 209398 209399 209551 209557 209559 209560 209563 209567 209572 209588 209706 209788 209799 209803 209804 209806 209808 209813 401192 401427 401871 454895 493669 5296593
• 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: 561 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 = BTL and Original Applicant = OHMEDA MEDICAL