| Class 2 Device Recall Ingenuity Core | |
Date Initiated by Firm | March 06, 2015 |
Date Posted | June 11, 2015 |
Recall Status1 |
Terminated 3 on March 13, 2017 |
Recall Number | Z-1771-2015 |
Recall Event ID |
71134 |
510(K)Number | K033326 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. |
Code Information |
Model #: 728321; Serial #s: 52000, 52001, 52002, 52004, 52006, 52007, 52008, 52009, 52010, 52013, 52015, 52016, 52017, 52018, 52020, 52021, 52022, 52024, 52026, 52033, 52038, 52039, 52046, 52051, 52052, 52057, 310001, 310002, 310003, 310004, 310005, 310006, 310007, 310009, 310010, 310011, 310012, 310013, 310014, 310015, 310016, 310017, 310018, 310019, 310020, 310021, 310022, 310024, 310025, 310026, 310027, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310036, 310037, 310038, 310040, 310041, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310056, 310057, 310059, 310060, 310061, 310062, 310063, 310064, 310065, 310066, 310068, 310069, 310070, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 310081, 310082, 310083, 310084, 310085, 310086, 310087, 310088, 310089, 310090, 310091, 310092, 310093, 310094, 310095, 310096, 310097, 310099, 310100, 310101, 310102, 310103, 310104, 310105, 310106, 310107, 310108, 310109, 310110, 310111, 310112, 310113, 310114, 310115, 310116, 310117, 310118, 310119, 310120, 310121, 310123, 310124, 310125, 310126, 310128, 310129, 310131, 310132, 310133, 310134, 310135, 310136, 310137, 310138, 310139, 310140, 310141, 310143, 310144, 310145, 310148, 310149, 310151, 310152, 310153, 310154, 310155, 310157, 310158, 310160, 310161, 310162, 310163, 310164, 310165, 310170, 310171, 333001, 333002, 333003, 333005, 333006, 333007, 333008, 333009, 333010, 333011, 333012, 333013, 333014, 333015, 333016, 333017, 333022, 333024, 333025, 333026, 333027, 333030, 333031, 333035, 333037, 333038, 333042, 333044, 333045, 333046, 333051, 333052, 333053, 333055, 333057, 333060, 333061, 333066. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact | Mr. Yuchol Kim 440-483-2015 |
Manufacturer Reason for Recall | The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers. |
Quantity in Commerce | 215 Units |
Distribution | Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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