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Terminated

Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI

FDA Recall Z-0821-2007 · Posted 2007-05-22

Recalling FirmGE Medical Systems LLC
Recall StatusTerminated
Product CodeIZL
Date Initiated2006-12-21
Date Terminated2008-02-24
Product Quantity6 units

Reason for Recall

When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.

Firm Action

Visit to each consignee beginning December 21, 2006.

Root Cause

Other

Distribution Pattern

Product was distributed in the following states: MS, NE, NJ, and, TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052897GE DEFINIUM AMX 700, MODEL AMX 700General Electric Medical Systems · 2005-11-08

Official Source

View FDA Recall →

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

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