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Terminated

Axiom Iconos R200 X-Ray

FDA Recall Z-1213-2010 · Posted 2010-03-27

Recall StatusTerminated
Product CodeJAA
Date Initiated2010-01-29
Date Terminated2010-08-11
Product Quantity169 units

Reason for Recall

table can tilt/move when it is not intended

Firm Action

The recalling firm has issued a letter to affected customers and will send technicians to apply the fix to each defective device.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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