Device recall: Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI…
Class II FDA enforcement event 85297. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
WELCH ALLYN, INC/MORTARA started this device recall on 18 Mar 2020. The firm address in the FDA record is in Milwaukee, WI. FDA put the recall in Class II. FDA event 85297 has 10 product records. The first FDA enforcement report date is 6 May 2020. The record gives the status Terminated, with the termination date 9 Feb 2026.
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 . openFDA export of .
Distribution
In the words of FDA.
US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON,…
Recalling firm
WELCH ALLYN, INC/MORTARA, Milwaukee, WI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
10 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1810-2020 | Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms. | 78,521 units total | Class II | Terminated | 6 May 2020 |
| Z-1811-2020 | ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files. | 78,521 units total | Class II | Terminated | 6 May 2020 |
| Z-1812-2020 | H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP. The 24-hour H12+ recorder uses a single AA alkaline battery to provide continuous 12-lead… | 78,521 units total | Class II | Terminated | 6 May 2020 |
| Z-1813-2020 | T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory. | 78,521 units total | Class II | Terminated | 6 May 2020 |
| Z-1814-2020 | X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP, PAT CBL 4WIRE AHA SNAP HC. | 78,521 units total | Class II | Terminated | 6 May 2020 |
| Z-1815-2020 | S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor provides a means to acquire and transmit… | 78,521 units total | Class II | Terminated | 6 May 2020 |
| Z-1816-2020 | Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW. The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable applications. | 78,521 units total | Class II | Terminated | 6 May 2020 |
| Z-1817-2020 | Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules. | 78,521 units total | Class II | Terminated | 6 May 2020 |
| Z-1818-2020 | Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system. | 78,521 units total | Class II | Terminated | 6 May 2020 |
| Z-1819-2020 | Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device names: LEAD SET WAM 10 WIRE BANANA AHA GRAY, LEAD SET WAM 10 WIRE BANANA IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS BANA AHA GRY, RPLCE LD SET WAM/AM12 LIMBS BANA IEC… | 78,521 units total | Class II | Terminated | 6 May 2020 |
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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2020
- 916
- Share of these events in Class II
- 93%
- Product records in this event
- 10Median of the firm: 4
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Sep 2021 | ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DD | Device | Class II | 1 |
| 31 Mar 2021 | ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1 | Device | Class II | 4 |
| 11 Nov 2020 | ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1810-2020The 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 85297. https://recallregister.com/fda/ii/85297/. Source: openFDA enforcement reports. Data through .
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:
US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON,…
- What quantity of product is in FDA event 85297?
- The event has 10 product records. The first record gives this quantity:
78,521 units total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 93% of the 916 device events that started in 2020 are in Class II.