Recalls / —

—#136199

Product

MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K091195

Affected lot / code info

Model #: 728131; Serial #s: EP16E130006, EP16E130007, EP16E130009, EP16E130010, EP16E130012, EP16E130013, EP16E130014, EP16E130015, EP16E130016, EP16E130017, EP16E130020, EP16E130021, EP16E130022, EP16E130023, EP16E130025, EP16E130026, EP16E130027, EP16E130029, EP16E130030, EP16E130031, EP16E130033, EP16E130034, EP16E130035, EP16E130036, EP16E130037, EP16E130040, EP16E130041, EP16E130042, EP16E130043, EP16E130044, EP16E130045, EP16E130046, EP16E130047, EP16E130048, EP16E130049, EP16E130050, EP16E130051, EP16E130052, EP16E130053, EP16E130055, EP16E130056, EP16E130057, EP16E130058, EP16E130062, EP16E130063, EP16E130064, EP16E130065, EP16E130066, EP16E130067, EP16E130068, EP16E130069, EP16E130070, EP16E130071, EP16E130072, EP16E130073, EP16E130074, EP16E130075, EP16E130077, EP16E130078, EP16E130079, EP16E130080, EP16E130082, EP16E130083, EP16E130086, EP16E130087, EP16E130088, EP16E130089, EP16E130092, EP16E130093, EP16E130094, EP16E130095, EP16E130097, EP16E130098, EP16E130099, EP16E130100, EP16E130102, EP16E130103, EP16E130105, EP16E130106, EP16E130107, EP16E130109, EP16E130110, EP16E140001, EP16E140002, EP16E140003, EP16E140007, EP16E140008, EP16E140009, EP16E140010, EP16E140011, EP16E140012, EP16E140014, EP16E140015, EP16E140016, EP16E140017, EP16E140018, EP16E140019, EP16E140021, EP16E140022, EP16E140024, EP16E140025, EP16E140027, EP16E140029, EP16E140035, EP16E140039, EP16E140041, EP16E140042, EP16E140050, EP16E140057, EP16E140059, EP16E140075, EP16EB110006, EP16EB120006, EP16EB120007, EP16EB120008, EP16EB120009, EP16EB130001, EP16EB130002, EP16EB130003, P16E090027 & P16EM09002

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers.

Recalling firm

Firm

Philips Medical Systems (Cleveland) Inc

Address

595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2015-03-06

Posted by FDA

2015-06-11

Terminated

2017-03-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #136199. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.