Recall Z-0917-2014
GE Healthcare · initiated December 12, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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…
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 taken
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.
Details
- Recall number
- Z-0917-2014
- Initiated
- December 12, 2013
- Posted by FDA
- February 3, 2014
- Terminated
- June 1, 2015
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Quantity
- 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…
- Recalling firm
- GE Healthcare, Laurel, MD
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0912-2014 Class II | Giraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880…Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to… | 12/12/2013Terminated |
| Z-0913-2014 Class II | Panda iRes Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part…Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to… | 12/12/2013Terminated |
| Z-0914-2014 Class II | Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part…Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to… | 12/12/2013Terminated |
| Z-0915-2014 Class II | Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612…Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to… | 12/12/2013Terminated |
| Z-0916-2014 Class II | Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001…Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to… | 12/12/2013Terminated |