Reported Jul 3, 2019 · Terminated

ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/…

GE Healthcare, LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

ECG leadwire setsREF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106389-003 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in 2106389-004 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 130 cm/ 51 in 2106389-005 ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106389-006 ECG Leadwire set, 5-lead, grouped, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106390-001 ECG Leadwire set, 3-lead, grabber, AHA, 74 cm/ 29 in 2106390-002 ECG Leadwire set, 3-lead, grabber, AHA, 130 cm/ 51 in 2106390-003 ECG Leadwire set, 3-lead, grabber, IEC, 74 cm/ 29 in 2106390-004 ECG Leadwire set, 3-lead, grabber, IEC, 130 cm/ 51 in 2106391-001 ECG Leadwire set, 5-lead, grabber, AHA, 74 cm/ 29 in 2106391-002 ECG Leadwire set, 5-lead, grabber, AHA, 130 cm/ 51 in 2106391-003 ECG Leadwire set, 5-lead, grabber, IEC, 74 cm/ 29 in 2106391-004 ECG Leadwire set, 5-lead, grabber, IEC, 130 cm/ 51 in 2106391-005 ECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106391-006 ECG Leadwire set, 5-lead, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106393-001 ECG Leadwire set, 5-lead V2-6, grabber, AHA, 130 cm/ 51 in 2106393-002 ECG Leadwire set, 5-lead C2-6, grabber, IEC, 130 cm/ 51 in 2106393-003 ECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm/ 29 in 2106393-004 ECG Leadwire set, 5-lead C2-6, grabber, IEC, 74 cm/ 29 in 2106397-001 ECG Leadwire set, 6-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106397-002 ECG Leadwire set, 6-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106397-003 ECG Leadwire set, 6-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106398-001 ECG Leadwire set, 6-lead, grouped, grabber, IEC, 74 cm/ 29 in 2106398-002 ECG Leadwire set, 6-lead, grouped, grabber, 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

Lot codes and dates: 13 of 13 products
Products covered by this recall
Model / number Barcodes Product as published
2106389-001 00840682139960 —
2106389-002 00840682139779 2106389-003 none 2106389-004 none
2106389-005 00840682139786 2106389-006 none
2106390-001 00840682139687 —
2106390-002 00840682140232 2106390-003 none 2106390-004 none
2106391-001 00840682140799 —
2106391-002 00840682139830 2106391-003 none 2106391-004 none
2106391-005 00840682140348 2106391-006 none
2106393-001 00840682140287 2106393-002 none
2106393-003 00840682139885 2106393-004 none
2106397-001 00840682140522 —
2106397-002 00840682140461 —
2106397-003 00840682140041 2106398-001 none 2106398-002 none
Amount recalled: 58,045 units (31,108 US; 26937 OUS) in total

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

Nationwide
PR

Why it was recalled

ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from GE Healthcare, LLC

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX Aug 31, 2022
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700… Aug 17, 2022
Centricity PACS Software Version 7.0 SP0.0.4.7 Aug 3, 2022
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000 Jul 27, 2022
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and… Jul 13, 2022
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on… Jul 6, 2022

152 in total.

Where it was distributed

Puerto Rico recalls

All recall categories · Browse the whole archive

Model / number	Barcodes	Product as published
`2106389-001`	`00840682139960`	—
`2106389-002`	`00840682139779`	2106389-003 none 2106389-004 none
`2106389-005`	`00840682139786`	2106389-006 none
`2106390-001`	`00840682139687`	—
`2106390-002`	`00840682140232`	2106390-003 none 2106390-004 none
`2106391-001`	`00840682140799`	—
`2106391-002`	`00840682139830`	2106391-003 none 2106391-004 none
`2106391-005`	`00840682140348`	2106391-006 none
`2106393-001`	`00840682140287`	2106393-002 none
`2106393-003`	`00840682139885`	2106393-004 none
`2106397-001`	`00840682140522`	—
`2106397-002`	`00840682140461`	—
`2106397-003`	`00840682140041`	2106398-001 none 2106398-002 none