FDA Medical Device Recalls (openFDA)
SEDECAL SA: wDR 2.2 Mobile Digital Diagnostic X-Ray System
- Recall number
- Z-2045-2023
- Recalling firm
- SEDECAL SA
- Product
- wDR 2.2 Mobile Digital Diagnostic X-Ray System
- Status
- Open, Classified
- Initiated
- 2023-05-23
- Posted
- 2023-06-30
- Terminated
- not on file
- Reason
- There is a software login in issue that may prevent the user from logging in.
- Root cause
- Software change control
- Action
- A recall notification letter was mailed to customers in the United States by the US distributor, Philips, beginning May 23, 2023. Customers are advised to take the following actions: 1) To prevent the system from becoming inoperable, do not reboot or log out of your system until Philips has implemented the software correction. 2) Circulate this notice to all users of the device so that they are aware of the issue. 3) Complete and return the response form to Philips promptly and no later than 30 days from receipt. A Philips representative will contact consignees to schedule a time for a Field Service Engineer to visit the site and implement a software solution to resolve the issue.
- Quantity
- 1061 units
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K191813"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 3002495042
- Firm city
- Algete
- Firm state
- not on file
- Firm country
- Spain
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28