Recalls / —

—#34601

Product

AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641

FDA product code

DQK — Computer, Diagnostic, Programmable

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K020440

Affected lot / code info

Serial numbers: 4001-4008 and 4050-4056.

Why it was recalled

possible error calculating valve area with the AXIOM Sensis

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

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.

Timeline

Recall initiated

2004-07-09

Posted by FDA

2004-10-22

Terminated

2005-09-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #34601. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.