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Stand-Alone Resuscitation, T-Piece, part numbers… recallZ-0916-2014 · GE Healthcare · initiated Dec 12, 2013

Class II Terminated All recalls posted in February 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0916-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 12, 2013
Posted by the FDA
Feb 3, 2014
Recalling firm
GE Healthcare
Quantity
375 units
Product code
BTL
FDA submissions
K070210
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.

Product description

Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; 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 (models, lots, serial numbers)

Show the full code information (4k characters)

Serial Numbers: QABR50001 QABR50002 QABR50003 QABR50004 QABR50005 QABR50006 QABR50007 QABR50008 QABR50009 QABR50010 QABR50011 QABR50012 QABR50013 QABR50014 QABR50015 QABR50016 QABR50017 QABR50018 QABR50019 QABR50020 QABR50021 QABR50022 QABR50023 QABR50024 QABR50025 QABR50026 QABR50027 QABR50028 QABR50029 QABR50030 QABR50031 QABR50032 QABR50033 QABR50034 QABR50035 QABR50036 QABR50037 QABR50038 QABR50039 QABR50040 QABR50041 QABR50042 QABR50043 QABR50044 QABR50045 QABR50046 QABR50047 QABR50048 QABR50049 QABR50050 QABR50051 QABR50052 QABR50053 QABR50054 QABR50055 QABR50056 QABR50057 QABR50058 QABR50059 QABR50060 QABR50061 QABR50062 QABR50063 QABR50077 QABR50078 QABR50079 QABR50080 QABR50081 QABR50082 QABR50083 QABR50084 QABR50085 QABR50093 QABR50094 QABR50095 QABR50096 QABR50097 QABR50098 QABR50099 QABR50109 QABR50110 QABR50111 QABR50112 QABR50113 QABR50114 QABR50115 QABR50120 QABR50121 QABR50124 QABR50125 QABR50127 QABR50128 QABR50129 QABR50130 QABR50131 QABR50134 QABR50135 QABR50136 QABR50137 QABR50138 QABR50139 QABR50140 QABR50141 QABR50142 QABR50143 QABR50144 QABR50145 QABR50146 QABR50147 QABR50148 QABR50149 QABR50150 QABR50151 QABR50152 QABR50153 QABR50154 QABR50155 QABR50156 QABR50157 QABR50158 QABR50159 QABR50160 QABR50161 QABR50162 QABR50163 QABR50164 QABR50165 QABR50166 QABR50167 QABR50168 QABR50169 QABR50170 QABR50171 QABR50172 QABR50173 QABR50174 QABR50175 QABR50176 QABR50177 QABR50178 QABR50179 QABR50180 QABR50181 QABR50182 QABR50183 QABR50184 QABR50185 QABR50186 QABR50187 QABR50188 QABR50189 QABR50190 QABR50191 QABR50192 QABR50193 QABR50194 QABR50195 QABR50196 QABR50197 QABR50198 QABR50199 QABR50200 QABR50201 QABR50202 QABR50203 QABR50204 QABR50205 QABR50207 QABR50208 QABR50209 QABR50210 QABR50211 QABR50212 QABR50213 QABR50214 QABR50215 QABR50216 QABR50217 QABR50218 QABR50219 QABR50220 QABR50221 QABR50222 QABR50223 QABR50224 QABR50225 QABR50226 QABR50227 QABR50228 QABR50229 QABR50231 QABR50232 QABR50233 QABR50234 QABR50235 QABR50236 QABR50237 QABR50238 QABR50239 QABR50240 QABR50241 QABR50242 QABR50243 QABR50244 QABR50245 QABR50246 QABR50247 QABR50248 QABR50249 QABR50250 QABR50251 QABR50252 QABR50253 QABR50254 QABR50255 QABR50256 QABR50257 QABR50258 QABR50259 QABR50260 QABR50261 QABR50262 QABR50263 QABR50264 QABR50265 QABR50266 QABR50267 QABR50268 QABR50269 QABR50270 QABR50271 QABR50272 QABR50273 QABS50001 QABS50002 QABS50003 QABS50004 QABS50005 QABS50006 QABS50007 QABS50008 QABS50009 QABS50010 QABS50011 QABS50012 QABS50013 QABS50014 QABS50015 QABS50016 QABS50017 QABS50018 QABS50019 QABS50020 QABS50022 QABS50024 QABS50025 QABS50028 QABS50029 QABS50030 QABS50031 QABS50032 QABS50033 QABS50034 QABS50035 QABS50036 QABS50037 QABS50038 QABS50039 QABS50040 QABS50041 QABS50042 QABS50043 QABS50044 QABS50045 QABS50046 QABS50047 QABS50048 QABS50049 QABS50050 QABS50051 QABS50052 QABS50053 QABS50055 QABS50056 QABS50057 QABS50058 QABS50059 QABS50060 QABS50061 QABS50062 QABS50063 QABS50064 QABS50065 QABS50066 QABS50067 QABS50068 QABS50071 QABS50072 QABS50073 QABS50074 QABS50075 QABS50076 QABS50077 QABS50078 QABS50079 QABS50080 QABS50081 QABS50082 QABS50083 QABS50084 QABS50085 QABS50087 QABS50088 QABS50089 QABS50090 QABS50091 QABS50092 QABS50093 QABS50094 QABS50095 QABS50096 QABS50097 QABS50098 QABS50099 QABS50100 QABS50101 QABS50104 QABS50105 QABS50106 QABS50107 QABS50108 QABS50109 QABS50110 QABS50111 QABS50112 QABS50113 QABS50114 QABS50117 QABS50118 QABS50119 QABS50120 QABS50121 QABS50122 QABS50123 QABS50124 QABS50125 QABS50126 QABS50127 QABS50128 QABS50129 QABS50130 QABS50131 QABS50132 QABS50133 QABS50134 QABS50135 QABS50136 QABS50137 QABS50138 QABS50139 QABS50140 QABS50141 QABS50142 QABS50143 QABS50144 QABS50145 QABS50147 QABS50148 QABS50149 QABS50150 QABS50151 QABS50152 QABS50153 QABS50154 QABS50160

Other devices under the same FDA submission

1 device cleared under K070210 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 67225).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page