Device recall: Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

US: CA, IL, and NJ

SEDECAL SA, Algete, Spain.

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

FDA records how the recall started: Voluntary: Firm initiated.

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.

Device events that started in 2025

945

Share of these events in Class II

85%

Product records in this event

46Median of the firm: 1

Events of the firm on the register

7

SEDECAL SA: all 7 events

• FDA enforcement report Z-0242-2026The 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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Where was the product distributed?

The FDA record gives this distribution: US: CA, IL, and NJ

What quantity of product is in FDA event 97075?

The event has 46 product records. The first record gives this quantity: 56 units

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many device recalls of 2025 have the same class?

85% of the 945 device events that started in 2025 are in Class II.