Siemens Medical Solutions USA, Inc AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial numbers: 1155, 6002, 6006-6014, 6016, 6018-6021, 6023-6025, 6027-6053, 8006-8007, 8009-8010, and 8050-8055. Model number 66 48 161 involves the following serial numbers: 11001-11014, 11016, 11018, and 11050-11054.
Products Sold
Serial numbers: 1155, 6002, 6006-6014, 6016, 6018-6021, 6023-6025, 6027-6053, and 6100-6125. Model number 66 34 641 involves the following serial numbers: 4001-4008 and 4050-4056. Model number 66 34 658 involves the following serial numbers: 8001-8003, 8006-8007, 8009-8010, and 8050-8055. Model number 66 48 161 involves the following serial numbers: 11001-11014, 11016, 11018, and 11050-11054.
Siemens Medical Solutions USA, Inc is recalling AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974. due to possible error calculating valve area with the AXIOM Sensis. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
possible error calculating valve area with the AXIOM Sensis
Recommended Action
Per FDA guidance
The recalling firm has issued a Customer Advisory to the affected customers per Update Instructions AX053/04/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AR, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, MS, MO, NE, NY, NC, OH, OK, PA, SC, TX, VA, WA, WV
Page updated: Jan 10, 2026