Class 2 Device Recall Philips MX 16Slice CT Scanner System

• Date Initiated by Firm: December 19, 2012
• Date Posted: February 28, 2013
• Recall Status: Terminated on December 03, 2013
• Recall Number: Z-0899-2013
• Recall Event ID: 64389
• 510(K)Number: K083498
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
• 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
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Chester McCoy; 800-722-9377 Ext. 5
• Manufacturer Reason for Recall: The four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAK