Recall Z-1879-2019 ยท DSA Cable, Transducer And Electrode, Patient, (Including Connector)
GE Healthcare, LLC
Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 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.
| Date | May 10, 2019 |
| Status | Terminated |
| Reason | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm. |
| Root cause | 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 |
| Quantity | 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 Salvado |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.