SEDECAL SA: Medical Device Recall in 2023 - (Recall #: Z-2045-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

wDR 2.2 Mobile Digital Diagnostic X-Ray System

Product Classification:

Class II

Date Initiated: May 23, 2023

Date Posted: July 5, 2023

Recall Number: Z-2045-2023

Event ID: 92464

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1061 units

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

Voluntary or Mandated:

Voluntary: Firm initiated