RecallDepth

Gyroscan NT-Intera 1.5T

Company
Philips Medical Systems
Recall Initiated
May 2, 2002
Posted
September 12, 2003
Terminated
April 11, 2005
Recall Number
Z-1200-03
Quantity
see above
Firm Location
Bothell, WA

Reason for Recall

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

Distribution

The firm distributed units to hospitals and medical centers nationwide.

Lot / Code Info

Serial numbers provided above

Root Cause

Other

Action Taken

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.

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