Recall Z-0251-2026— SEDECAL SA

Name: FDA recall Z-0251-2026
Creator: U.S. Food and Drug Administration
Published: 2025-06-10

Class II · Ongoing

Class II FDA medical device recall by SEDECAL SA, initiated 2025-06-10. It names one FDA 510(k) clearance: K161345. Product: Model Number 40KWFXPLUS-710CW, Mobile X-ray system. Reason: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning..

Recalling firm: SEDECAL SA
Classification: Class II
Status: Ongoing
Initiated: 2025-06-10
Firm location: Algete, Spain

510(k) clearances named in this recall

1 on FDA's record

K161345 — RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa.·cleared 2016-07-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Model Number 40KWFXPLUS-710CW, Mobile X-ray system

Reason for recall

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Data sourced from openFDA. This site is unofficial and independent of the FDA.