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Recall Observatory FDA recall evidence

Device product

wDR 2.2 Mobile Digital Diagnostic X-Ray System

Z-2045-2023

May 23, 2023

Class II

Product summary

Firm
SEDECAL SA
Event
Event 92464
Status
Ongoing
Classification
Class II
Quantity
1061 units
Official record key
device-enforcement:Z-2045-2023

Official wording

Reason: There is a software login in issue that may prevent the user from logging in.

Code information: 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 pattern: 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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software login in issue