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.
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 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
- 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
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
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