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Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-le...

FDA Device Recall #Z-1878-2019 — Class III — May 10, 2019

Recall Summary

Recall Number Z-1878-2019
Classification Class III — Low risk
Date Initiated May 10, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Healthcare, LLC
Location Waukesha, WI
Product Type Devices
Quantity 58,045 units (31,108 US; 26937 OUS) in total

Product Description

Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire set, 5-lead, snap, IEC, 130 cm/ 51 in 2106381-005 ECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106383-001 ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 in 2106383-002 ECG Leadwire set, 5-lead, grouped, snap, AHA, 130 cm/ 51 in 2106383-003 ECG Leadwire set, 5-lead, grouped, snap, IEC, 74 cm/ 29 in 2106383-004 ECG Leadwire set, 5-lead, grouped, snap, IEC, 130 cm/ 51 in 2106383-005 ECG Leadwire set, 5-lead, grouped, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106383-006 ECG Leadwire set, 5-lead, grouped, snap, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106385-001 ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 in 2106385-002 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, AHA, 130 CM/ 51 IN 2106385-003 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 74 CM/ 29 IN 2106385-004 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 130 CM/ 51 IN 2106394-003 ECG Leadwire set, 5-lead V2-6, snap, AHA, 74 cm/ 29 in 2106395-001 ECG Leadwire set, 6-lead, grouped, snap, AHA, 74 cm/ 29 in 2106396-001 ECG Leadwire set, 6-lead, grouped, snap, IEC, 74 cm/ 29 in 2106396-002 ECG Leadwire set, 6-lead, grouped, snap, IEC, 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.

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.

Distribution Pattern

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.

Lot / Code Information

product does not have lot or serial codes REF/Catalog Number GTIN/UDI 2106381-001 00840682139953 2106381-002 00840682140201 2106381-003 none 2106381-004 none 2106381-005 00840682139854 2106383-001 00840682140126 2106383-002 00840682140096 2106383-003 none 2106383-004 none 2106383-005 00840682140034 2106385-001 00840682139588 2106385-002 00840682140119 2106385-003 none 2106385-004 none 2106394-003 00840682140102 2106395-001 00840682139649 2106396-001 none 2106396-002 none

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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