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Devices
Device Recall Ingenuity Flex
모델명 / 제조번호(시리얼번호)
901475, 901476, 901495, 901505, 901509, 901513, 901529, 901532, 901539, 901541
의료기기 분류등급
Radiology Devices
의료기기 등급
2
이식된 장치?
No
유통
Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
제품 설명
Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
Manufacturer
Philips Medical Systems (Cleveland) Inc
1 Event
Device Recall Ingenuity Flex 의 리콜
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제조사
Philips Medical Systems (Cleveland) Inc
제조사 주소
Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
제조사 모회사 (2017)
Philips
Source
USFDA
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Device Recall Ingenuity Flex
모델명 / 제조번호(시리얼번호)
Model #: 728317; Serial #s: 260002, 260003, 340002, 340003, 345001, 345002, 345003, 345004, 345005, 345006, 345007, 345010, 345012, 345013, 345014, 345016, 345017, 345018, 345022, 345023, 345024, 345028 & 345029.
의료기기 분류등급
Radiology Devices
의료기기 등급
2
이식된 장치?
No
유통
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.
제품 설명
Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Language
English
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