Gyroscan ACS-NT system
FDA Recall Z-1199-03 · Posted 2003-09-12
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Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeLNH
Date Initiated2002-05-02
Date Terminated2005-04-11
Product Quantity112 total for all 3 devices
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.
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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