Device Recall PHILIPS MODEL MX 16slice Computed Tomography Scanners

Serial numbers are: P16C080002, P16E080005, P16E080007, P16E080008, P16E080012, P16E080010, P16E090004, P16E090008, P16E090005, P16E080007, P16E080008, P16E080012, P16E080010, P16E090004, P16E090008, P16E090005, P16E090006, P16E090007, P16E090009, P16E090012, P16E090003, P16E090010, P16E090011, P16E090013, P16EM09003, P16EM09004, P16E090002, P16E090014, P16E090015, P16EM08003, P16E090016, P16E090018, P16E090019, P16E090020, P16E090021, P16E090026, EP16E090001, P16E090028, P16E090027, P16E090017, P16EM09002, P16E090024, P16E090025, EP16E090002, EP16E090003, EP16E090004, EP16E090006, EP16E090007, EP16E090008, EP16E090009, P16C090001, EP16E090010, EP16E090011, EP16E090012, EP16E090014, EP16E090015, EP16E100001, EP16E100002, EP16E100004, EP16E100003, EP16E100005, EP16E100006, EP16E100007, EP16E090013, EP16E100008, EP16E100009, EP16E100010, P16C100001, EP16E100011, EP16E100012, EP16E100013, EP16E100014, EP16E100015, EP16E100016, EP16E100017, EP16E100018, EP16E100019, P16C080001, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100027, EP16E100026, EP16E100030, EP16E100031, EP16E100029, P16C100003, EP16E100025, EP16E100028, P16C100002, EP16E100034, EP16E100033, EP16E100032, EP16E100035, EP16E100036, EP16E100037, P16E100002, P16C100004, EP16E100039, EP16E100038, EP16E100042, EP16E100043, EP16E100041, EP16E100044, EP16E100046, EP16E100045, EP16E100048, EP16E100047, EP16E100051, EP16E100049, EP16E100050, EP16E100053, EP16E100052, EP16E100054, EP16E100056, EP16E100055, P16C100005, EP16E100057, EP16E100058, EP16E100059, EP16E100060, EP16E100061, EP16E100062, EP16E100063, P16C100007, EP16E100067, EP16ER100003, EP16ER100004, EP16ER100005, EP16E100070, EP16E100069, EP16E100071, EP16E100072, EP16E100073, EP16E100074, EP16E100078, EP16E100075, EP16E100076, EP16E100077, EP16E100079, EP16E100080, EP16E100082, EP16E100081, EP16E100083, EP16E100084, P16C100008, P16C100009, EP16E100085, EP16E100086, EP16E100087, P16C100010, EP16E100088, EP16E100089, EP16E100090, EP16E100091, EP16E100093, EP16E100094, EP16E100092, P16C100014, P16C100015, EP16E100095, P16C100011, EP16E100096, EP16E100097, EP16E100098, P16C100017, EP16E100099, EP16E100100, EP16E100101, EP16E100102, P16C100013, EP16E100103, EP16E100104, EP16E100105, EP16E100106, EP16E100109, EP16E100107, P16C100012, EP16E100108, EP16E100111, EP16E100110, P16C100018, EP16E100112, EP16ER100008, EP16ER100007, EP16E100113, EP16E110003, EP16E110001, EP16E110002, EP16E110004, and EP16E110005.

Radiology Devices

2

No

Worldwide Distribution -- United States (AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, SC and TX) including Puerto Rico and countries of Albania, Argentina, Australia, Belgium Brazil, Chile, Columbia, Dominican Republic, Ecuador, Germany, Greece, India, Indonesia, Italy, japan, Kenya, Lebanon, Malawi, The Netherlands, Philippines, Poland, Romania, Saudi Arabia, South Africa, Spain, Switzerland, Turkey, Uganda, United Arab Emirates and Venezuela

MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371. || The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients.