The Recall Desk
ModerateFDA (Devices)·Z-1482-2021·Announced 2021-04-28

Welch Allyn ELI 280 Electrocardiograph Recalled for Safety Standard Non-Compliance

Welch Allyn is recalling 99 ELI 280 Electrocardiographs because they do not meet IEC 60601-2-27 safety requirements as labeled.

What this means for you

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 does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity recall involving a safety standard non-compliance without reported harm.

Plain-English summary

Welch Allyn Inc Mortara is recalling 99 units of the ELI 280 Electrocardiograph, which includes 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, specifically electrocardiographic monitoring systems. The source text does not report any illnesses, injuries, or deaths associated with this defect.

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. Users should identify their device by checking the part number and serial number against the list provided in the official recall notice. If a device is affected, users should contact Welch Allyn for instructions on corrective action.

The recalled product

Product
ELI 280 Electrocardiograph, 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 — Cardiac Monitoring
Hazard
Affected units
99

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: ELI280-LDB-ADAAX (Device Identifier: 732094265699)
  • 118230000580
  • 118230000570
  • 118230000584
  • 118230000569
  • 118230000572 118230000582
  • 118230000574
  • 118230000576
  • 118230000577
  • 118230000581
  • 118230000568
  • 118230000575
  • 118230000583
  • 118230000578
  • 118230000571
  • 118230000567
  • 118340001621
  • 118340001622
  • 118340001623
  • 118400001475

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 →