Recall Z-1754-2024— SEDECAL SA

Name: FDA recall Z-1754-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-22

Class II · Ongoing

Class II FDA medical device recall by SEDECAL SA, initiated 2024-01-22. It names one FDA 510(k) clearance: K161345. Product: Battery 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. MobileDiagnost wDR.. Reason: Potential interference with the anti-fall system..

Recalling firm: SEDECAL SA
Classification: Class II
Status: Ongoing
Initiated: 2024-01-22
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

Battery 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. MobileDiagnost wDR.

Reason for recall

Potential interference with the anti-fall system.

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