# FDA recall Z-2045-2023

> **SEDECAL SA** · Class II · device recall initiated 2023-05-23.

## Product

wDR 2.2 Mobile Digital Diagnostic X-Ray System

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2045-2023
- **Recalling firm:** SEDECAL SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-23
- **Report date:** 2023-07-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Algete, N/A, Spain

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2045-2023

## Citation

> AI Analytics. FDA recall Z-2045-2023. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2045-2023. Source: US FDA. Licensed CC0.

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