Gyroscan ACS-NT system
- Company
- Philips Medical Systems
- Recall Initiated
- May 2, 2002
- Posted
- September 12, 2003
- Terminated
- April 11, 2005
- Recall Number
- Z-1199-03
- Quantity
- 112 total for all 3 devices
- 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
X1753, X1412, X1595, X1662, 102718, X1757, X1693, X1523, X1740, X1742, 86293, 101206, 86292, X0717, X1602, X1563, X1670, X1648, X1582, 10009, 10353, 86280, 13057, 13056, 4139, 87605, 84700, 86968, 10082, 87604, 86082, 101111, 84899, 87183, 87161, 87146, 86020, 87135, 86121, 86080, 101608, X0083, 87148, 87145, 83306, 83303, 86184, 86147, 84478, 87188, X1759, 86559, 85685, 102095, 83804, 100460, 85433, 83802, 82678, 85119, 83946, 84433, 86019, 83301, 84861, 84860, 87527, 84820, 100786, 84477, 100785, 86083, 101072, 100459, 83325, 84887, 86056, 87147, 83396, 86596, 85684, 62832, 85500, 85688, 86406, 86411, 100916, 85422, 100469, 85686, 86407, 87310, 87309, 86595, 85139, 85172, 63046, 101408, 85141, 86335, 86317, 87033, 85157, 101165, 38317, 86334, 47189,86287, 86288, 101429, 87053
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.