AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658
FDA Recall Z-0035-05 · Posted 2004-10-22
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeDQK
Date Initiated2004-07-09
Date Terminated2005-09-13
Product Quantity143 units
Reason for Recall
possible error calculating valve area with the AXIOM Sensis
Firm Action
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.
Root Cause
Other
Distribution Pattern
The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.