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Terminated

Magnetom Avanto. Magnetic Resonance Imaging System. Model number 7391167

FDA Recall Z-1528-05 · Posted 2005-09-09

Recall StatusTerminated
Product CodeLNN
Date Initiated2005-08-12
Date Terminated2006-07-19
Product Quantity209 units

Reason for Recall

there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore

Firm Action

The recalling firm issued via certified mail a Customer Safety Advisory to the affected customers per Update Instructions MR031/05/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities and MRI facilities nationwide.

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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