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Terminated

MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system.

FDA Recall Z-0704-06 · Posted 2006-09-30

Recalling FirmGE OEC Medical Systems,Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2006-03-28
Date Terminated2011-07-25
Product Quantity534 units (Domestic), 125 (Intl)

Reason for Recall

Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.

Firm Action

Consignees were notified by letter prior to 04/28/2006.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992506MINI 6800 DIGITAL MOBILE C-ARMGe Dec Medical Systems · 1999-08-19

Official Source

View FDA Recall →

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

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