Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Surveyor S12/S19 Bedside Patient Monitor Recalled by Welch Allyn Inc Mortara Due to Devices do not meet IEC 60601-2-27 requirements as...

Date: March 31, 2021
Company: Welch Allyn Inc Mortara
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Welch Allyn Inc Mortara directly.

Affected Products

Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.

Quantity: 213 units

Why Was This Recalled?

Devices do not meet IEC 60601-2-27 requirements as labeled.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Welch Allyn Inc Mortara

Welch Allyn Inc Mortara has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report