The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1484-2021·Announced 2021-04-28

Welch Allyn Surveyor Bedside Patient Monitor Recalled for Safety Standard Non-Compliance

Welch Allyn is recalling 213 Surveyor S12/S19 Bedside Patient Monitors because they do not meet IEC 60601-2-27 safety requirements as labeled.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of the product could cause temporary or medically reversible health consequences. The source text does not report any injuries, illnesses, or fatalities, and the hazard is a compliance issue with safety standards rather than a reported acute failure.

Plain-English summary

Welch Allyn Inc Mortara is recalling 213 units of the Surveyor S12/S19 Bedside Patient Monitor, equipped with the AM12M Acquisition Module accessory. The specific software version of the AM12M affected by this recall is version 1.5.1. These devices are indicated for use on adult and pediatric populations.

The recall was initiated because the devices do not meet IEC 60601-2-27 requirements as labeled. This standard pertains to the safety of medical electrical equipment for patient monitoring. The affected units were distributed nationwide in the United States, specifically in the states of California, Colorado, Florida, Georgia, Indiana, Louisiana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Texas, Utah, and Virginia.

Healthcare facilities and consumers should identify affected units by checking the part numbers and serial numbers listed in the official recall documentation. Users should stop using the affected devices and contact Welch Allyn for instructions on repair, replacement, or return.

The recalled product

Product
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.
Manufacturer
Welch Allyn Inc Mortara
Category
Medical Device — Patient Monitor
Hazard
Affected units
213

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Part Number: SUR19-FDH-XXXAX (Device Identifier: 732094288926)
  • S/N: 118300000441
  • 118300000440
  • 118300000438
  • 118300000439
  • 118350000999
  • 118350000998
  • 118350000997
  • 118350000996
  • 119100001366
  • 119100001369
  • 119100001367
  • 120140001434
  • 120140001435 Part Number: SUR19-LDH-BXXAX (Device Identifier: 732094261585)
  • S/N: 117430592474
  • 117430592471
  • 117430592472
  • 117430592473
  • 117430592475
  • 117430592476 Part Number: SUR19-LDH-XXXAX (Device Identifier: 732094261578)

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Welch Allyn Inc Mortara under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Welch Allyn Inc Mortara

See all →

Same hazard · safety standard non compliance

See all →

Similar recalls