Philips Medical Systems (Cleveland) Inc: Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.

Recall number

Z-0899-2013

Recalling firm

Philips Medical Systems (Cleveland) Inc

Product

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

Status

Terminated

Initiated

2012-12-19

Posted

2013-02-28

Terminated

2013-12-03

Reason

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

Root cause

Component design/selection

Action

Philips Healthcare sent an Urgent - Medical Device Correction letter dated December 14, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to have BioMedical Engineering personnel inspect the patient table top screws that secure it to the carrier. Customers were instructed that If it is found that the table top screws are improperly seated, they should stop using the system and contact their local Philips Field Service Engineer for repair. A Philips Field Service Engineer will schedule a time to inspect and repair all the affected systems. For further information customers were instructed to contact their Philips Healthcare Customer Care Solutions Center at 1-800-722-9377 and follow the recorded menu option to reach a Customer Solutions. For questions regarding this recall call 800-722-9377, ext 5.

Quantity

412 Units

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K083498"]

PMA numbers

not on file

Product code

JAK

Firm FEI

1525965

Firm city

Cleveland

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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