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Terminated

Axiom Sensis. Programmable Diagnostic Computer

FDA Recall Z-0979-03 · Posted 2003-07-03

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeDQK
Date Initiated2003-02-28
Date Terminated2004-04-08
Product Quantity4 units

Reason for Recall

software problem - erroneous results or system crashes

Firm Action

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.

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020440NEWCORSiemens Medical Systems, Inc. · 2002-12-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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