BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Reported: December 15, 2021 Initiated: November 12, 2021 #Z-0355-2022
Product Description
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Reason for Recall
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 22 units US
- Distribution
- Worldwide distribution - US Nationwide and the countries of Afghanistan, Algeria, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cameroon, Chile, China, Colombia, Cook Islands, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives Mali, Martinique, Mauritius, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia, Zimbabwe.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075. Recalled by Philips North America Llc. Units affected: 22 units US.
Why was this product recalled? ▼
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 15, 2021. Severity: Moderate. Recall number: Z-0355-2022.
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