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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenuity Core 128

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 Class 2 Device Recall Ingenuity Core 128see related information
Date Initiated by FirmMarch 06, 2015
Date PostedJune 11, 2015
Recall Status1 Terminated 3 on March 13, 2017
Recall NumberZ-1772-2015
Recall Event ID 71134
510(K)NumberK033326 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductIngenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Code Information Model #: 728323; Serial #s: 30153, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32010, 32011, 32013, 32014, 32015, 32016, 32018, 32021, 32023, 32025, 32026, 32029, 32030, 32031, 32032, 32033, 32034, 32035, 32036, 32037, 32038, 32040, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32051, 32052, 32053, 32054, 32057, 32059, 32060, 32062, 32064, 32066, 32068, 32069, 32070, 32072, 32073, 32074, 32077, 32078, 32080, 32083, 32084, 32089, 32091, 32092, 32094, 32095, 32098, 32100, 32101, 32104, 32106, 32107, 32108, 300137, 310067, 320001, 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320018, 320019, 320020, 320021, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320030, 320031, 320032, 320033, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320073, 320074, 320075, 320076, 320077, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320085, 320086, 320087, 320088, 320089, 320090, 320092, 320093, 320095, 320096, 320097, 320098, 320099, 320101, 320102, 320103, 320104, 320105, 320106, 320107, 320109, 320110, 320111, 320112, 320114, 320115, 320116, 320117, 320118, 320119, 320120, 320121, 320122, 320123, 320124, 320125, 320126, 320128, 320129, 320131, 320132, 320133, 320134, 320135, 320137, 320138, 320139, 320140, 320141, 320142, 320143, 320144, 320145, 320146, 320147, 320148, 320150, 336001, 336002, 336003, 336006, 336007, 336008, 336009, 336010, 336011, 336012, 336013, 336014, 336015, 336016, 336018, 336020, 336021, 336024, 336027, 336028, 336029, 336030, 336031, 336032, 336033, 336034, 336035, 336036, 336037, 336038, 336039, 336040, 336042, 336043, 336044, 336046, 336047, 336048, 336050, 336052, 336055, 336056, 336057, 336058, 336059, 336061, 336063, 336066, 336067, 336068, 336069, 336070, 336071, 336072, 336074, 336075, 336076, 336080, 336081, 336086, 336087, 336089, 336702, 336703, 336704, 336705, 336706, 336708, 336709, 336710, 336711, 336713, 336714, 336715, 336716, 336717, 336718, 336719, 336721, 336707
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information ContactMr. 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
ActionOn 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers.
Quantity in Commerce288 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = JAK
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