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.
Check against the official notice below — it lists the full affected range.
Welch Allyn Inc Mortara is recalling 746 units of the AM12M Acquisition Module accessory (software version 1.5.1), which is used with adult and pediatric patients. The devices do not meet IEC 60601-2-27 requirements as labeled. The affected devices were distributed nationwide in California, Colorado, Florida, Georgia, Indiana, Louisiana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Texas, Utah, and Virginia. Specific serial numbers are identified for three part numbers: 41000-037-50, 41000-037-51, and 9293-065-50.
The recall notice does not specify a remedy or recommended action for consumers who may have these devices.
Written by software from the official notice below. Not reviewed by a lawyer.
Devices do not meet IEC 60601-2-27 requirements as labeled.
Reason for recall: Devices do not meet IEC 60601-2-27 requirements as labeled. Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA. Quantity: 746 units Lot/code info: 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, 118
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.