Recalls / —

—#27920

Product

Gyroscan ACS-NT system

FDA product code

LNH — System, Nuclear Magnetic Resonance Imaging

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K932645

Affected 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

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Philips Medical Systems

Address

22100 Bothell Everett Highway, Bothell, Washington 98041

Distribution

Distribution pattern

The firm distributed units to hospitals and medical centers nationwide.

Timeline

Recall initiated

2002-05-02

Posted by FDA

2003-09-12

Terminated

2005-04-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27920. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.