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Terminated

Gyroscan NT-Intera 1.5T

FDA Recall Z-1200-03 · Posted 2003-09-12

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeLNH
Date Initiated2002-05-02
Date Terminated2005-04-11
Product Quantitysee above

Reason for Recall

Patient burns related to high SAR levels and the combined use of Synergy Body Coil and synergy Flex-M coil

Firm Action

The firm issued a Field Change Order to their field personnel instructing them to add new labeling to the User Manual. 05/02/2002 A letter was issued to customers.

Root Cause

Other

Distribution Pattern

The firm distributed units to hospitals and medical centers nationwide.

Official Source

View FDA Recall →

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

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