wDR 2.2 Mobile Digital Diagnostic X-Ray System
Enforcement
- Recall Number
- Z-2045-2023
- Event ID
- 92464
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SEDECAL SA
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- July 5, 2023
- Initiation Date
- May 23, 2023
- Classification Date
- June 30, 2023
- Address
- PELAYA, 9 POL., POL. IND. RIO DE JANEIRO, Algete, N/A, N/A, Spain
Description
wDR 2.2 Mobile Digital Diagnostic X-Ray System
There is a software login in issue that may prevent the user from logging in.
Model MobileDiagnost wDR: 1) Model Number 712007, Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3 2) Model Number 712006, Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3 3) Model Number 712004, Software version 2.1 with Windows 10 Upgrade 4) Model Number 712002, Software version 2.1 with Windows 10 Upgrade
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
1061 units