Q-Stress/XScribe — Class II medical device recall Z-1817-2020
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-1817-2020 |
|---|---|
| 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 | QS-6XX-XXXXX, XSCRIBE-5XX-XXXXX, XSCRIBE-6XX-XXXXX |
Product
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.
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-1817-2020. 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.