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Terminated

Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data.

FDA Recall Z-1251-2011 · Posted 2011-02-15

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2009-10-02
Date Terminated2011-02-17
Product Quantity379 units

Reason for Recall

New protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts.

Firm Action

Elekta sent Important Notice Affected Product: Fixation Posts, A331, dated June 22, 2009. The Important Notice will be added to the Customer User manual upon receipt.

Root Cause

Labeling design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972324LEKSELL STEREOTACTIC SYSTEMElekta Instrument AB · 1998-03-02

Official Source

View FDA Recall →

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

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