Recall Register

SEDECAL SA: FDA recalls

FDA enforcement reports name SEDECAL SA as the recalling firm in 7 events. The events have 53 product records. The recalls started from 2021 to 2025. All the events are device recalls.

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 .

Enforcement events

7 events, newest first.

FDA enforcement events of SEDECAL SA
InitiatedProduct (first record)TypeClassRecordsStatus
10 Jun 2025Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)DeviceClass II46Ongoing
22 Jan 2024Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j.…DeviceClass II1Ongoing
13 Dec 2023Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.DeviceClass II1Ongoing
23 May 2023wDR 2.2 Mobile Digital Diagnostic X-Ray SystemDeviceClass II1Ongoing
6 Feb 2023Phoenix mKDR, digital mobile diagnostic x-ray systemDeviceClass II2Ongoing
12 Aug 2022Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500DeviceClass II1Ongoing
14 Oct 2021MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007DeviceClass II1Ongoing

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

SEDECAL SA: events for each product type
TypeEvents
Device7
SEDECAL SA: events in each class
ClassEvents
Class II7
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
7

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.

Events by year

FDA enforcement events of SEDECAL SA, by the year that the recall started. The largest year is 2023, with 3 events.

Official channels

Cite this page

Recall Register. SEDECAL SA: FDA recalls. https://recallregister.com/firm/sedecal-sa/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of SEDECAL SA have?
Class II: 7 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of SEDECAL SA?
FDA event 97075, which the firm started on 10 Jun 2025. The first product in the record is: Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
How many FDA recalls of SEDECAL SA have the status Ongoing?
7 events have the status Ongoing in the openFDA file. openFDA says 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.