ClearanceBrief
Recall Z-0979-03 ยท DQK Computer, Diagnostic, Programmable

Siemens Medical Solutions USA, Inc

Axiom Sensis. Programmable Diagnostic Computer

DateJul 3, 2003 (initiated Feb 28, 2003)
StatusTerminated
Reasonsoftware problem - erroneous results or system crashes
Root causeOther
ActionThe 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.
Quantity4 units
DistributionThe product was shipped two medical facilities in MA and MI and two units were used as demonstration units by the recalling firm.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K020440NEWCOR
Siemens Medical Systems, Inc., Dec 3, 2002