Reported May 8, 2024 · Ongoing

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

Sedecal Sa

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SEDECAL SA · PELAYA, 9 POL. · Algete · N/A

Is this the product you have?

10 of 10 products

Products covered by this recall
#Product as published
1SM-20HF-Batt
2SM-32HF-Batt
3SM-40HF-Batt
4SM-50HF-Batt
5SM-40-HF-B-D-VIR
6SM-20HF-B-D-KM (AeroDR X30)
7SM-32-HF-B-D-KM (AeroDR X30)
8SM-40HF-B-D-KM (AeroDR X30)
9SM-50HF-B-D-KM (AeroDR X30)
10MobileDiagnost wDR.
Lot codes and dates

10 of 10 products

Products covered by this recall
#BarcodesProduct as published
108436046001497SM-20HF-Batt - UDI-DI 08436046001497
208436046001503SM-32HF-Batt - UDI-DI 08436046001503
308436046001510SM-40HF-Batt - UDI-DI 08436046001510
408436046001527SM-50HF-Batt - UDI-DI 08436046001527
508436046002166SM-40-HF-B-D-VIR - UDI-DI 08436046002166
608436046002579SM-20HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002579
708436046002586SM-32-HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002586
808436046002593SM-40HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002593
908436046002609SM-50HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002609
1008436046002357MobileDiagnost wDR - UDI-DI 08436046002357.
Amount recalled
636 devices

Where it was sold

Why it was recalled

Potential interference with the anti-fall system.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

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