Z-1485-2021Class II

AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 -

Name: Z-1485-2021 AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 -
Creator: Welch Allyn Inc Mortara
Published: 2021-03-31
License: https://open.fda.gov/license/

Mortara Instrument, Inc. / initiated 2021-03-31 / Terminated / root cause: manufacturing process

FDA source

Welch Allyn Inc Mortara began a recall of AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric... on 2021-03-31. FDA classified it as Class II and gives the reason as "Devices do not meet IEC 60601-2-27 requirements as labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1485-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-31
Posted: 2021-04-22
Terminated: 2024-08-16
Recalling firm: Mortara Instrument, Inc.
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.
Product code: DPS Electrocardiograph
Reason for recall: Devices do not meet IEC 60601-2-27 requirements as labeled.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall notification letters were mailed to customers notifying them of the potential issue with recommended actions beginning April 7, 2021. The notification letter includes an acknowledgement form that must be returned to the recalling firm. Once the customer confirms the impacted units are in possession, the recalling firm will arrange for an exchange AM12M to be provided. The recalled unit will be returned to the recalling firm's service center for processing.
Quantity in commerce: 746 units
Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.
Product codes and lots: 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, 118180635011, 116510544918 Part Number: 41000-037-51 (Device Identifier: 812345029673); S/N: 118330001224, 118330001229, 118330001226, 118330001222, 118330001221, 118330001223, 118330001225, 118330001228, 118330001230, 118330001227, 118370000736, 118350001181, 118410000928, 118410000929, 119140000221, 119140000222, 119140000223, 119420001690, 120070000301, 120070000300, 120070000297, 120070000302, 120070000295, 120070000299, 120070000296, 120070000298, 118070612689, 116440535497, 116440535498, 116440535499, 116440535500, 116530547301, 116530547302, 116530547303, 116530547304, 117040552121, 117040552122, 117040552123, 117040552124, 118130624261, 118130624262 Part Number: 9293-065-50 (Device Identifier: 812345029710); S/N: 118260000305, 118260000306, 118260000307, 118260000308, 118260000309, 118260000310, 118260000311, 118260000855, 118260000856, 118260000857, 118260000858, 118260000859, 118260000860, 118260000861, 118260000862, 118290001080, 118290001081, 118290001082, 118290001083, 118290001084, 118290001085, 118290001088, 118290001090, 118290001091, 118290001093, 118290001094, 118290001097, 118330000945, 118330000946, 118330000950, 118330000952, 118340001214, 118340001215, 118340001221, 118380002053, 118380002063, 118410000049, 118410000050, 118410000053, 118410000055, 118410000056, 118410000057, 118410000058, 118410000059, 118410000060, 118410000061, 118410000063, 118410000065, 118410000066, 118410000067, 118410000113, 118410000114, 118450000570, 118450000571, 118450000572, 118450000573, 118450000574, 118450000575, 118450000576, 118450000577, 118450000578, 118450000579, 118450000580, 118450000581, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1485-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1482-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-22
Z-1483-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-22
Z-1484-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-22
Z-1485-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-22

Product code DPS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)