FDA-Device2023-07-05Class II
wDR 2.2 Mobile Digital Diagnostic X-Ray System
SEDECAL SA
Hazard
There is a software login in issue that may prevent the user from logging in.
Sold states
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
Affected count
1061 units
Manufactured in
PELAYA, 9 POL., POL. IND. RIO DE JANEIRO, Algete, N/A, Spain
Products
wDR 2.2 Mobile Digital Diagnostic X-Ray System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2045-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief