Philips Medical Systems (Cleveland) Inc: The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Agency Publication Date: May 22, 2015

Affected Products

Product: MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

MX8000 Dual v. EXP: System Code #, 728130, Serial #, 8107, 8128, 8152, 8157, 8171, 8212, 8236, 8245, 8263, 8320 & 8357.

Product: Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

System Code #, 728243, Serial #, 7039

Product: Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

System Code #, 728231, Serial #, 9568, 9758, 10097, 10143, 10267, 10269, 10275, 10427, 10436, 10521, 10545, 10579, 10622, 90097, 90218, 95203, 95319, 95328, 95362, 95369, 95391, 95414, 95427, 95433, 95471, 95486, 95544, 95586, 95604, 95605, 95617, 95628, 95632, 95640, 95672, 95752, 95754 & 95757.

Product: Brilliance CT 40. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

System Code #, 728235, Serial #, 90071 & 90178.

Product: Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

System Code #, 728240, Serial #, 60008.

Product: Brilliance CT 16 Water. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

System Code #, 728245, Serial #, 3500.

Product: Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

System Code #, 728246, Serial #, 3376, 3393, 3444, 3466, 3650, 4055, 5234, 5239, 5311, 5366, 5387, 5388, 5403, 5408, 5417, 5418, 5420, 5421, 5422, 5427, 5450, 5483, 5484, 5497, 5503, 5507, 5574, 5610, 5614, 5626, 5639, 5692, 5729, 5736, 5800, 5804, 5853, 5905, 5909, 5925, 5927, 5989, 5993, 6128, 6149, 6232, 6308, 6313, 6322, 6351, 6384, 6389, 6462, 6488, 6604, 30061, 50002, 50033, 50048, 50062, 50065, 50069, 50080, 50095, 50097, 50099, 50137 & 500006.

Product: Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

System Code #, 728256, Serial #, 2448, 3145, 3212, 3213, 3276, 3278, 280, 3307, 3309, 3317, 3336, 30003, 30008, 30017, 30021, 30022, 30036 & 30047.

Product: Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

System Code #, 728256, Serial #, 2448, 3145, 3212, 3213, 3276, 3278, 280, 3307, 3309, 3317, 3336, 30003, 30008, 30017, 30021, 30022, 30036 & 30047.

Product: Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

System Code #, 728306, Serial #, 100067, 100137, 100179, 100226, 100233, 100293, 100294 & 100342.

Product: Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

System Code #, 728326, Serial #, 300130.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71177

Status: Resolved

Manufacturer: Philips Medical Systems (Cleveland) Inc

Manufactured In: United States

Units Affected: 11 products (153 units total)

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Sources: FDA iRES · Raw API Response

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Affected Products

MX8000 Dual v. EXP: System Code #, 728130, Serial #, 8107, 8128, 8152, 8157, 8171, 8212, 8236, 8245, 8263, 8320 & 8357.

System Code #, 728243, Serial #, 7039

System Code #, 728235, Serial #, 90071 & 90178.

System Code #, 728240, Serial #, 60008.

System Code #, 728245, Serial #, 3500.

System Code #, 728256, Serial #, 2448, 3145, 3212, 3213, 3276, 3278, 280, 3307, 3309, 3317, 3336, 30003, 30008, 30017, 30021, 30022, 30036 & 30047.

System Code #, 728306, Serial #, 100067, 100137, 100179, 100226, 100233, 100293, 100294 & 100342.

System Code #, 728326, Serial #, 300130.