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Terminated

AXIOM Luminos TF, model number 10093902 Intended to be used for procedures that involve high skin doses, which can result in deterministic effects.

FDA Recall Z-0101-2009 · Posted 2008-10-10

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2008-08-12
Date Terminated2009-10-05
Product Quantity211 units

Reason for Recall

Liquids may enter the system and cause potential malfunction and possible hazard to patients, user or other persons.

Firm Action

The recalling firm was made aware of a potential problem with the device from the manufacturer in Germany. The recalling firm sent a copy of the Customer Safety Advisory Notice, dated June 18, 2008, received from Germany to their customers. The recalling firm has representatives visiting each location to modify the units.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051602AXIOM SIRESKOP SDSiemens Medical Systems, Inc. · 2005-07-07

Official Source

View FDA Recall →

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

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