Device recall: ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002…

Class III FDA enforcement event 82937. Recall start date: 10 May 2019. Status in the FDA record: Terminated. Termination date: 24 May 2024.

Reason for recall, in the words of FDA

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

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

GE Healthcare, LLC started this device recall on 10 May 2019. The firm address in the FDA record is in Waukesha, WI. FDA put the recall in Class III. FDA event 82937 has 5 product records. The first FDA enforcement report date is 3 Jul 2019. The record gives the status Terminated, with the termination date 24 May 2024.

FDA enforcement report The 5 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil,…

Recalling firm

GE Healthcare, LLC, Waukesha, WI.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

5 product records in the event.

FDA event 82937: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1875-2019	ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4 ft. 2106306-001 ECG Trunk Cable, Neonatal, DIN…	58,045 units (31,108 US; 26937 OUS) in total	Class III	Terminated	3 Jul 2019
Z-1876-2019	ECG leadwire sets: REF/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,…	58,045 units (31,108 US; 26937 OUS) in total	Class III	Terminated	3 Jul 2019
Z-1877-2019	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…	58,045 units (31,108 US; 26937 OUS) in total	Class III	Terminated	3 Jul 2019
Z-1878-2019	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…	58,045 units (31,108 US; 26937 OUS) in total	Class III	Terminated	3 Jul 2019
Z-1879-2019	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.	58,045 units (31,108 US; 26937 OUS) in total	Class III	Terminated	3 Jul 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class III: 6%
Product records in this event: 5Median of the firm: 1
Events of the firm on the register: 225

Other events of the firm

Other FDA enforcement events of GE Healthcare, LLC
Initiated	Product (first record)	Type	Class	Records
27 Feb 2026	SIGNA Premier systems	Device	Class II	1
15 Jul 2022	(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3	Device	Class II	1
24 Jun 2022	SIGNA Premier magnetic resonance scanner, model 5748519.	Device	Class II	1
14 Jun 2022	Centricity PACS Software Version 7.0 SP0.0.4.7	Device	Class II	1
8 Jun 2022	GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within	Device	Class II	1
2 Jun 2022	Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Cap	Device	Class II	1
1 Jun 2022	GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia Syste	Device	Class I	1
27 May 2022	GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part	Device	Class II	1
10 May 2022	CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and	Device	Class II	1
28 Apr 2022	Centricity Universal Viewer Zero Footprint Client	Device	Class II	5

GE Healthcare, LLC: all 225 events

Official channels

FDA enforcement report Z-1875-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 82937. https://recallregister.com/fda/iii/82937/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil,…
What quantity of product is in FDA event 82937?: The event has 5 product records. The first record gives this quantity: 58,045 units (31,108 US; 26937 OUS) in total
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 6% of the 968 device events that started in 2019 are in Class III.