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Terminated

Axiom Artis MP X-Ray System

FDA Recall Z-0818-05 · Posted 2005-05-11

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2005-04-01
Date Terminated2005-08-18
Product Quantity21 units

Reason for Recall

potential problem with the fluoroscopy switch on the power grip

Firm Action

The recalling firm''s Customer Service Engineers are visiting each account to correct/replace the Power Grip button.

Root Cause

Other

Distribution Pattern

The products were shipped to hospitals in AL, AZ, DC, DE, IA, MI, NC, NE, PA, RI, TX, WA, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010721AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEMSiemens Medical Corp. · 2001-03-30

Official Source

View FDA Recall →

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

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