Welch Allyn, Inc. 901138 (REF SUR19-XDH-XXXAX)Recalls & reported problems
Welch Allyn, Inc. · Surveyor S19 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2/3/4, Cardiac Output, resistive color touchscreen 18.5" display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; AM12 Wired Acquisition Module with AHA 12-lead lead set with snap ends and 1 IEC 5 wire ECG patient cable with clip ends; No invasive blood pressure cable; No cardiac output cable; No printer; LAN; No mounting options · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00732094321449), received between Jun 21, 2024 and Sep 7, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (2 reports).
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Mar 31, 2021Class IITerminated
Devices do not meet IEC 60601-2-27 requirements as labeled.
Z-1484-2021 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- No Audible Alarm2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50651707 ↗MalfunctionJun 21, 2024No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THAT THE S19 UNIT DID NOT SOUND AN ALARM WHEN VENTRICULAR FIBRILLATION WAS DETECTED BY THE SURVEYOR CENTRAL WITH A RED ALERT. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583147 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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