Skip to content
Recall Observatory FDA recall evidence

Device product

CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1784-2015

March 06, 2015

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 71134
Status
Terminated
Classification
Class II
Quantity
81 units
Official record key
device-enforcement:Z-1784-2015

Official wording

Reason: 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.

Code information: Model #: 882450; Serial #s: 1106080, 1122002, 2112702, 3101001, 4042003, 4112402, 5032201, 5032902, 5042501, 5060701, 6030802, 7092001, 9042902, 9053001, 9061602, 9070702, 9081002, 9083101, 9083102, 9090301, 9090302, 9091101, 9092201, 9092202, 9101302, 9101901, 9102302, 9102801, 9102802, 9111601, 9111602, 9120902, 10020201, 10062906, 10071301, 10090201, 10090202, 10100501, 10100502, 10100701, 10100702, 10110303, 10110801, 10110802, 10120901, 10120902, 10121001, 10121002, 11021601, 11021602, 11031001, 11031002, 11041201, 11041202, 11051101, 11051102, 11070401, 11070402, 11072102, 11090801, 11090802, 11112301, 11120501, 11120502, 11121201, 11121202, 11121402, 12010601, 12012702, 12020101, 12020102, 12041201, 12052201, 12053001, 12053002, 12071101, 12071102, 12071201, 12071401, 110110804 & 110110806.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.