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Class 3 Device Recall Replacement leadwires with grabber ends |
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Date Initiated by Firm |
May 10, 2019 |
Create Date |
June 26, 2019 |
Recall Status1 |
Completed |
Recall Number |
Z-1877-2019 |
Recall Event ID |
82937 |
Product Classification |
Cable, transducer and electrode, patient, (including connector) - Product Code DSA
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Product |
Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in
The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter. |
Code Information |
product does not have lot or serial codes No GTIN/UDI |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact |
800-437-1171
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Manufacturer Reason for Recall |
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
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FDA Determined Cause 2 |
Process design |
Action |
The firm, GE Healthcare, initiated a "URGENT MEDICAL DEVICE CORRECTION"letter dated 05/10/2019. The letter explained the reason for recall and provided the following safety instructions:
The affected ECG trunk cables and leadwires may continue to be used for monitoring only. Discontinue use of the affected ECG trunk cables and leadwires for patients where an arrhythmia that might require defibrillation is foreseeable, and in these patients use unaffected ECG trunk cables and leadwires.
If defibrillation turns out to be unexpectedly needed when the affected ECG trunk cables and leadwires are being used just for monitoring, follow the instructions below:
1) Disconnect ALL ECG leadwires from the patient.
2) Defibrillate the patient per hospital protocol.
3) If it is possible to monitor the patients rhythm using defibrillator ECG leadwires or pads please do so. If this is not possible, reconnect ECG leadwires after the patients rhythm has been defibrillated.
The recalled products will be replaced.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
Quantity in Commerce |
58,045 units (31,108 US; 26937 OUS) in total |
Distribution |
Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malta, Mauritius, Mexico, Moldova, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Palestine (state of), Panama, Poland, Qatar, Republic of Serbia, Romania, Russia, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Vietnam. |
Total Product Life Cycle |
TPLC Device Report
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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.
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