Welch Allyn X12+ Telemeter Patient Cable Recall: Defibrillation Risk
Welch Allyn recalls X12+ Telemeter patient cables that may not meet defibrillation safety standards. Affected units could pose a risk during medical use. Contact Welch Allyn for details.
Recall notice
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Contact the company
What happened, in plain English
Welch Allyn is recalling patient cables for their X12+ Telemeter that may not meet safety standards for defibrillation. This could pose a risk during medical procedures if the device is used improperly. Read more at govinfonow.com/recall/65617-welch-allyn-x12-telemeter-patient-cable-recall-defibrillation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/65617-welch-allyn-x12-telemeter-patient-cable-recall-defibrillation-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1814-2020
Cite this page
“Welch Allyn X12+ Telemeter Patient Cable Recall: Defibrillation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65617-welch-allyn-x12-telemeter-patient-cable-recall-defibrillation-risk. Based on FDA recall #Z-1814-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1814-2020%22&limit=1).
Why it’s dangerous
The recalled patient cables may not meet safety standards for defibrillation. This means they could fail under electrical stress during medical procedures, potentially causing harm to patients or users.
Who’s affected
Healthcare professionals using Welch Allyn X12+ Telemeters with the specific patient cables listed are most at risk. Patients using these devices may also be affected.
How to tell if you have this one
Check for model numbers starting with X12PLUS-XXX-XXXXX or specific cable identifiers like PAT CBL 10WIRE LEADFORM AHA SNAP. These cables were sold with Welch Allyn X12+ Telemeters between 2020 and 2022.
- Brand
Welch Allyn- Category
Medical device
All 10 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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, OR, PA, PR, RI, SC, SD, TN,UT, VA, VT, WA, WI, WV and WY.
| Recall number | Product, codes & lots |
|---|---|
| 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.; Model Numbers: ELI10-XXX-XXXXX, ELI350-XXX-XXXXX, ELI150C-XXX-XXXXX, ELI250C-XXX-XXXXX, ELI230-XXX-XXXXX, ELI280-XXX-XXXXX, ELI380-XYYZZ, RSCRIBE-xxx-xxxxx and CC-XXX-XXXX. |
| 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.; Model Numbers: 11066-XXX-50, 41000-029-XX. |
| 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 data recorded over a 24-hour period and a removable 24-hour compact flash (CF) card for data storage.; Model Numbers: H12PLUS-XXX-XXXXX, 9293-017-50, 9293-017-51, 9293-026-50, 9293-026-51. |
| 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.; Model Numbers: T12-XXX-XXXXX, T12S-XXX-XXXXX. |
| 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.; Model Numbers: X12PLUS-XXX-XXXXX, 9293-017-50, 9293-017-51, 9293-026-50, 9293-026-51, 9293-034-50 |
| 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 simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the WiFi network.; Model Numbers: S4-Q-ASX-XXX, S4-Q-AXX-XXX, S4-P-A, 9293-061-50, 9293-061-51, 9293-061-52, 9293-061-53. |
| 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.; Model Numbers: SUR12-XXX-XXXXX, SUR19-XXX-XXXXX, 9293-033-52, 9293-033-53. |
| 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.; Model Numbers: QS-6XX-XXXXX, XSCRIBE-5XX-XXXXX, XSCRIBE-6XX-XXXXX. |
| Z-1818-2020 | Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.; Same as X12+ Model Number X12PLUS-XXX-XXXXX |
| 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 GRY, RPLCE LD SET WAM/AM12 V1-V3 BANA AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 BANA IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 BANA AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 BANA IEC GRY, LEAD SET AM15E 13-WIRE BANANA AHA GRAY, LEAD SET AM15E 13-WIRE BANANA IEC GRAY, RPLCE LEAD SET AM15E E2-E4 BANANA AHA GRAY, LEAD SET WAM 10 WIRE CLIPS AHA GRAY, LEAD SET WAM 10 WIRE CLIPS IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS CLIP AHA GRY, RPLCE LD SET WAM/AM12 LIMBS CLIP IEC GRY, RPLCE LD SET WAM/AM12 V1-V3 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 CLIP IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 CLIP IEC GRY, LEAD SET WAM/AM12 10-WIRE BANANA AHA GRY, LEAD SET WAM/AM12 10-WIRE BANANA IEC GRY, LD SET WAM/AM12 10 WRE SHORT AHA CLIP, LD SET WAM/AM12 10 WRE SHORT IEC CLIP.; Model Numbers: 9293-046-60 - 9293-047-71; 9293-017-50 - 9293-017-51; 9293-026-50 - 9293-026-51; 9293-061-50 - 9293-061-53; 9293-033-52 - 9293-033-53 and 9293-034-50. |
What to do — step by step
Check Product Model
Look for model numbers starting with X12PLUS-XXX-XXXXX or specific cable identifiers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 49 states.
FDA 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, OR, PA, PR, RI, SC, SD, TN,UT, VA, VT, WA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 5.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1814-2020 (March 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1814-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.