Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

wDR 2.2 Mobile Digital Diagnostic X-Ray System Recalled by SEDECAL SA Due to There is a software login in issue that...

Date: May 23, 2023
Company: SEDECAL SA
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SEDECAL SA directly.

Affected Products

wDR 2.2 Mobile Digital Diagnostic X-Ray System

Quantity: 1061 units

Why Was This Recalled?

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

Where Was This Sold?

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

About SEDECAL SA

SEDECAL SA has 53 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report