Device recall: wDR 2.2 Mobile Digital Diagnostic X-Ray System
Class II FDA enforcement event 92464. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
There is a software login in issue that may prevent the user from logging in.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
SEDECAL SA started this device recall on 23 May 2023. The firm address in the FDA record is in Algete. FDA put the recall in Class II. FDA event 92464 has 1 product record. The first FDA enforcement report date is 5 Jul 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distribution throughout United States including Puerto Rico and US Virgin Islands OUS distribution to Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Botswana, Brazil,…
Recalling firm
SEDECAL SA, Algete, N/A, Spain.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2045-2023 | wDR 2.2 Mobile Digital Diagnostic X-Ray System | 1061 units | Class II | Ongoing | 5 Jul 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Jun 2025 | Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30) | Device | Class II | 46 |
| 22 Jan 2024 | Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; | Device | Class II | 1 |
| 13 Dec 2023 | Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It a | Device | Class II | 1 |
| 6 Feb 2023 | Phoenix mKDR, digital mobile diagnostic x-ray system | Device | Class II | 2 |
| 12 Aug 2022 | Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500 | Device | Class II | 1 |
| 14 Oct 2021 | MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2045-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 92464. https://recallregister.com/fda/ii/92464/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distribution throughout United States including Puerto Rico and US Virgin Islands OUS distribution to Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Botswana, Brazil,…
- What quantity of product is in FDA event 92464?
- The FDA record gives this quantity:
1061 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.