Z-2045-2023Class II

wDR 2.2 Mobile Digital Diagnostic X-Ray System

Name: Z-2045-2023 wDR 2.2 Mobile Digital Diagnostic X-Ray System
Creator: Sedecal Sa
Published: 2023-05-23
License: https://open.fda.gov/license/

Sedecal S.A. / initiated 2023-05-23 / Open, Classified / root cause: software

FDA source

SEDECAL SA began a recall of wDR 2.2 Mobile Digital Diagnostic X-Ray System on 2023-05-23. FDA classified it as Class II and gives the reason as "There is a software login in issue that may prevent the user from logging in". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2045-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-23
Posted: 2023-06-30
Recalling firm: Sedecal S.A.
Product: wDR 2.2 Mobile Digital Diagnostic X-Ray System
Product code: IZL System, X-Ray, Mobile
Reason for recall: There is a software login in issue that may prevent the user from logging in.
Root cause tag: software
FDA 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2045-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2045-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-30

Product code IZL

K191813Class IIMobileDiagnost wDR 2.2Sedecal., Sa. / cleared 2019-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)