Reported May 31, 2017 · Terminated
AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
- Lot codes and dates
Model no.: 10764561110076416623974663463366346416634658
- Serial Numbers
744 of 744 codes
2052302122722035620020200592563257125812582258925931000181000364102161082041336533813382346080012005623483411342820380206343112338322417610122264229123362411260122215806025082236525862587258860301340534063440340734083437222676108435466041060138604122407315640108
- Amount recalled
- 4,095
Where it was sold
- Nationwide
Why it was recalled
An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Perform a system check prior to performing exams. If the Sensis system fails, its functions can not be used. Clinical treatment may need to be terminated, restarted, or transferred to a functioning system.
This product could cause temporary or reversible health problems — stop using it.
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