Gyroscan 1.5T Intera
This recall has been terminated (originally issued September 12, 2003).
- Company
- Philips Medical Systems
- Recall Initiated
- May 2, 2002
- Posted
- September 12, 2003
- Terminated
- April 11, 2005
- Recall Number
- Z-1201-03
- Quantity
- see above
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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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