X12+ and patient cable for the X12+ Telemeter with the following… — Class II medical device recall Z-1814-2020
Terminated recall by WELCH ALLYN, INC/MORTARA, reported 2020-05-06, distributed nationwide. Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medi
| Recall number | Z-1814-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | WELCH ALLYN, INC/MORTARA, Milwaukee, WI, United States |
| Recall initiated | 2020-03-18 |
| Classified | 2020-04-29 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2026-02-09 |
| Distributed | Nationwide (US) |
| Quantity | 78,521 units |
| Model numbers | 9293-017-50, 9293-017-51, 9293-026-50, 9293-026-51, 9293-034-50, X12PLUS-XXX-XXXXX |
Product
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.
Reason for recall
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1814-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.