SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain
Lot Codes / Batch Numbers
d. SM-50HF-Batt - UDI-DI 08436046001527, e. SM-40-HF-B-D-VIR - UDI-DI 08436046002166, f. SM-20HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002579, g. SM-32-HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002586, h. SM-40HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002593, i. SM-50HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002609, j. MobileDiagnost wDR - UDI-DI 08436046002357.
Products Sold
All serial numbers of model 3.1 Battery Mobile X-ray Unit EASY MOVING are affected. Following are the UDI numbers involved: a. SM-20HF-Batt - UDI-DI 08436046001497 b. SM-32HF-Batt - UDI-DI 08436046001503 c. SM-40HF-Batt - UDI-DI 08436046001510; d. SM-50HF-Batt - UDI-DI 08436046001527; e. SM-40-HF-B-D-VIR - UDI-DI 08436046002166; f. SM-20HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002579; g. SM-32-HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002586; h. SM-40HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002593; i. SM-50HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002609; j. MobileDiagnost wDR - UDI-DI 08436046002357.
SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain is recalling Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF- due to Potential interference with the anti-fall system.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential interference with the anti-fall system.
Recommended Action
Per FDA guidance
The firm issued letters dated 1/22/2024 via email to notify their distributor customers of the potential problem that could occur and the availability of a service kit that corrects the anomaly. The letter informs the distributor that a service kit has been created to install a new cable without the interference point in all of the installed bases of the devices. This kit contains parts for updating the parachute safety system making it similar to the one in production for the current product release. The entire installed base of Mobile System 3.1 must be inspected using the provided instructions in SIN 23-08-22 and the kit installed using the instructions in SIN 23-04-10 immediately if the cable could interfere with the parachute system. If no damage is found during the inspection, the kit can be installed in the next cable replacement scheduled according to the Service Manual instruction. An Acknowledgment Form was enclosed for completion and return as soon as possible that the distributor understands the letter. An Acknowledgment of Action Implemented was also enclosed for completion and return as soon as possible.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026