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SEDECAL SA recalls wDR 2.2 Mobile Digital Diagnostic X-Ray System
Recalled July 5, 2023 · FDA recall Z-2045-2023 · SEDECAL SA
Hazard
There is a software login in issue that may prevent the user from logging in. · FDA Class II
Units
1061 units
Sold at
Distribution throughout United States including Puerto Rico and US Virgin Islands OUS distribution to Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Hungary, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia,Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, and Zambia
Description
There is a software login in issue that may prevent the user from logging in.
Product
wDR 2.2 Mobile Digital Diagnostic X-Ray System
Manufacturer(s)
SEDECAL SA
Made in
Spain
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →