Data Foundry

Medical device recalls 2020

Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor… — Class II medical device recall Z-1816-2020

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 numberZ-1816-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmWELCH ALLYN, INC/MORTARA, Milwaukee, WI, United States
Recall initiated2020-03-18
Classified2020-04-29
Reported by FDA2020-05-06
Terminated2026-02-09
DistributedNationwide (US)
Quantity78,521 units
Model numbers9293-033-52, 9293-033-53, SUR12-XXX-XXXXX, SUR19-XXX-XXXXX

Product

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.

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-1816-2020. 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.