SEDECAL SA recalls Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF

Recalled May 8, 2024 · FDA recall Z-1754-2024 · SEDECAL SA

Hazard

Potential interference with the anti-fall system. · FDA Class II

Units

636 devices

Sold at

Worldwide distribution - US Nationwide in the states of CA, IL, NJ, and areas yet to be identified by Philips Medical Systems DMC GmbH, Hamburg, Germany.

Description

Potential interference with the anti-fall system.

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.

Manufacturer(s)

SEDECAL SA

Made in

Spain

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →