The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1485-2021·Announced 2021-04-28

Welch Allyn AM12M Acquisition Module Recalled for IEC 60601-2-27 Non-Compliance

Welch Allyn Inc Mortara is recalling 746 AM12M Acquisition Modules because they do not meet IEC 60601-2-27 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, and the source text describes a labeling/compliance issue without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Welch Allyn Inc Mortara is recalling 746 units of the AM12M Acquisition Module accessory. The recall affects software version 1.5.1 of the device, which is 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. The affected units were distributed nationwide in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.

Healthcare facilities and consumers should check their AM12M Acquisition Modules for the specific part numbers and serial numbers listed in the official recall notice to determine if they are affected. If a unit is affected, users should follow the instructions provided by Welch Allyn Inc Mortara for remediation or replacement.

The recalled product

Product
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 — Cardiac Monitoring
Hazard
Affected units
746

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: 41000-037-50 (Device Identifier: 812345029666)
  • S/N: 119030001449
  • 119030001451
  • 119030001447
  • 119030001450
  • 119190000644
  • 117200568671
  • 116520545406
  • 118030607566
  • 117510602011
  • 117060553537
  • 118030607568
  • 118030607569
  • 118030607570
  • 117270577273
  • 117200568670
  • 117060553536
  • 117120556677
  • 117220571046
  • 116530547186

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 →

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