Recalls / —

—#26731

Product

Axiom Sensis. Programmable Diagnostic Computer

FDA product code

DQK — Computer, Diagnostic, Programmable

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K020440

Affected lot / code info

Part numbers 6623974 and 6634633. Serial numbers 06011, 06012, 06018, and 02016.

Why it was recalled

software problem - erroneous results or system crashes

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued a Customer Safety Advisory Letter to their customers. The letter instructed the customer to insert the letter into their operator''s manual and that updated software would be released in May 2003.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Parkway, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

The product was shipped two medical facilities in MA and MI and two units were used as demonstration units by the recalling firm.

Timeline

Recall initiated

2003-02-28

Posted by FDA

2003-07-03

Terminated

2004-04-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #26731. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.