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Recall Observatory FDA recall evidence

Device product

Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.

Z-0899-2013

December 19, 2012

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 64389
Status
Terminated
Classification
Class II
Quantity
412 Units
Official record key
device-enforcement:Z-0899-2013

Official wording

Reason: The four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.

Code information: System Code #, 728131, Serial #: EP16E090001, EP16E090002, EP16E090003, EP16E090004, EP16E090006, EP16E090007, EP16E090008, EP16E090009, EP16E090010, EP16E090011, EP16E090012,EP16E090013, EP16E090015, EP16E100001, EP16E100004, EP16E100006, EP16E100008, EP16E100010, EP16E100011, EP16E100012, EP16E100013, EP16E100015, EP16E100016, EP16E100017, EP16E100018, EP16E100019, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100025, EP16E100026, EP16E100027, EP16E100028, EP16E100029, EP16E100030, EP16E100031, EP16E100032, EP16E100033, EP16E100034, EP16E100035, EP16E100036, EP16E100037, EP16E100038, EP16E100039, EP16E100041, EP16E100043, EP16E100044, EP16E100045, EP16E100046, EP16E100047, EP16E100048, EP16E100049, EP16E100051, EP16E100052, EP16E100055, EP16E100056, EP16E100057, EP16E100058, EP16E100059, EP16E100060, EP16E100061, EP16E100062, EP16E100063, EP16E100067, EP16E100069, EP16E100070, EP16E100071, EP16E100072, EP16E100073, EP16E100074, EP16E100075, EP16E100076, EP16E100077, EP16E100078, EP16E100079, EP16E100080, EP16E100081, EP16E100082, EP16E100083, EP16E100084, EP16E100085, EP16E100086, EP16E100087, EP16E100088, EP16E100090, EP16E100091, EP16E100092, EP16E100093, EP16E100094, EP16E100095, EP16E100096, EP16E100099, EP16E100100, EP16E100101, EP16E100102, EP16E100103, EP16E100105, EP16E100106, EP16E100107, EP16E100108, EP16E100109, EP16E100110, EP16E100111, EP16E100112, EP16E100113, EP16E110003, EP16E110005, EP16E110006, EP16E110007, EP16E110008, EP16E110009, EP16E110011, EP16E110012, EP16E110013, EP16E110014, EP16E110015, EP16E110017, EP16E110018, EP16E110019, EP16E110020, EP16E110021, EP16E110023, EP16E110024, EP16E110025, EP16E110026, EP16E110027, EP16E110028, EP16E110029, EP16E110030, EP16E110031, EP16E110032, EP16E110033, EP16E110034, EP16E110035, EP16E110037, EP16E110038, EP16E110039, EP16E110042, EP16E110043, EP16E110044, EP16E110045, EP16E110046, EP16E110047, EP16E110048, EP16E110049, EP16E110050, EP16E110051, EP16E110052, EP16E110054, EP16E110055, EP16E110056, EP16E110057, EP16E110058, EP16E110060, EP16E110062, EP16E110063, EP16E110064, EP16E110067, EP16E110069, EP16E110070, EP16E110074, EP16E110075, EP16E110077, EP16E110078, EP16E110080, EP16E110083, EP16E110084, EP16E110085, EP16E110089, EP16E110090, EP16E110091, EP16E110092, EP16E110093, EP16E110095, EP16E110096, EP16E110097, EP16E110099, EP16E110100, EP16E110101, EP16E110102, EP16E110104, EP16E110105, EP16E110106, EP16E110107, EP16E110108, EP16E110109, EP16E110110, EP16E110111, EP16E110115, EP16E110117, EP16E110118, EP16E110119, EP16E120003, EP16E120004, EP16E120005, EP16E120006, EP16E120007, EP16E120008, EP16E120009, EP16E120010, EP16E120011, EP16E120013, EP16E120014, EP16E120015, EP16E120016, EP16E120017, EP16E120019, EP16E120021, EP16E120023, EP16E120024, EP16E120025, EP16E120026, EP16E120027, EP16E120029, EP16E120030, EP16E120031, EP16E120032, EP16E120033, EP16E120034, EP16E120035, EP16E120036, EP16E120037, EP16E120039, EP16E120040, EP16E120041, EP16E120042, EP16E120043, EP16E120044, EP16E120045, EP16E120046, EP16E120047, EP16E120048, EP16E120050, EP16E120051, EP16E120052, EP16E120055, EP16E120056, EP16E120058, EP16E120059, EP16E120060, EP16E120061, EP16E120063, EP16E120065, EP16E120067, EP16E120068, EP16E120070, EP16E120071, EP16E120072, EP16E120074, EP16E120075, EP16E120076, EP16E120078, EP16E120081, EP16E120083, EP16E120088, EP16E120089, EP16EB110003, EP16EB110004, EP16EB110005, EP16EB110006, P16C080001, P16C080002, P16C100001, P16C100002, P16C100003, P16C100004, P16C100005, P16C100007, P16C100008, P16C100009, P16C100010, P16C100011, P16C100012, P16C100013, P16C100014, P16C100015, P16C100017, P16C100018, P16C110001, P16C110002, P16C110003, P16C110004, P16C110005, P16C110006, P16C110007, P16C110008, P16C110011, P16C110012, P16C110013, P16C110014, P16C110015, P16C110016, P16C110017, P16C110018, P16C110019, P16C110020, P16C110021, P16C110022, P16C110023, P16C110024, P16C110025, P16C110026, P16C110027, P16C110028, P16C110029, P16C110030, P16C110031, P16C110032, P16C110033, P16C110034, P16C110035, P16C110036, P16C110037, P16C120001, P16C120002, P16C120003, P16C120006, P16C120007, P16C120008, P16C120009, P16C120011, P16C120012, P16C120014, P16C120016, P16C120017, P16C120018, P16C120019, P16C120020, P16C120021, P16C120022, P16C120023, P16C120024, P16C120025, P16C120026, P16C120027, P16C120029, P16C120030, P16E080007, P16E080008, P16E090002, P16E090003, P16E090004, P16E090005, P16E090006, P16E090008, P16E090009, P16E090010, P16E090011, P16E090012, P16E090013, P16E090014, P16E090015, P16E090016, P16E090017, P16E090018, P16E090019, P16E090020, P16E090021, P16E090024, P16E090025, P16E090026, P16E090027, P16E090028, P16EF80010, P16EM08003, P16EM09002, P16EM09003, P16EM09004 System Code #, 728132, Serial #: EP16E100005, EP16E100007, EP16E110066, EP16ER100003, EP16ER100004, EP16ER100005, EP16ER100007, EP16ER100008, EP16ER110003, EP16ER110004, EP16ER110005, EP16ER110006, EP16ER110007, EP16ER110008, EP16ER110009, EP16ER110010, EP16ER110011, EP16ER110012, EP16ER110013, EP16ER110014, EP16ER110015, EP16ER110016, EP16ER110017, EP16ER110018, EP16ER110019, EP16ER110020, EP16ER110021, EP16ER110022, EP16ER110023, EP16ER120005, EP16ER120006, EP16ER120007, EP16ER120008, EP16ER120009, EP16ER120010, EP16ER120011, EP16ER120012, EP16ER120013, EP16ER120015, EP16ER120016 , EP16ER120017, EP16ER120018

Distribution pattern: Worldwide Distribution - USA including AL, AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NV, NY, OH, PA, PR and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.

Field note

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