Reported Apr 28, 2021 · Terminated
AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated…
Welch Allyn Inc. Mortara
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Welch Allyn Inc Mortara · 7865 N 86th St · Milwaukee, WI · 53224-3431
Is this the product you have?
- AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 -
- Product Usageindicated for use on adult and pediatric populations
- Lot codes and dates
- Part Number41000-037-50 (Device
- Identifier812345029666)
- S/N
119030001449119030001451119030001447119030001450119190000644117200568671116520545406118030607566117510602011117060553537118030607568118030607569118030607570117270577273117200568670117060553536117120556677117220571046116530547186118180635011116510544918
- Part Number41000-037-51 (Device
- Identifier812345029673)
- S/N
118330001224118330001229118330001226118330001222118330001221118330001223118330001225118330001228118330001230118330001227118370000736118350001181118410000928118410000929119140000221119140000222119140000223119420001690120070000301120070000300120070000297120070000302120070000295120070000299120070000296120070000298118070612689116440535497116440535498116440535499116440535500116530547301116530547302116530547303116530547304117040552121117040552122117040552123117040552124118130624261118130624262
- Part Number9293-065-50 (Device
- Identifier812345029710)
- S/N
684 of 684 codes
118260000305118260000306118260000307118260000308118260000309118260000310118260000311118260000855118260000856118260000857118260000858118260000859118260000860118260000861118260000862118290001080118290001081118290001082118290001083118290001084118290001085118290001088118290001090118290001091118290001093118290001094118290001097118330000945118330000946118330000950118330000952118340001214118340001215118340001221118380002053118380002063118410000049118410000050118410000053118410000055118410000056118410000057118410000058118410000059118410000060118410000061118410000063118410000065118410000066118410000067118410000113118410000114118450000570118450000571118450000572118450000573118450000574118450000575118450000576118450000577
- Amount recalled
- 746 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Devices do not meet IEC 60601-2-27 requirements as labeled.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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