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U.S. Department of Health and Human Services

Class 2 Device Recall RadPRO Mobile 40kW; RadPRO Mobile 40kW FLEXPLUS, Model SM40HFBDVIR

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  Class 2 Device Recall RadPRO Mobile 40kW; RadPRO Mobile 40kW FLEXPLUS, Model SM40HFBDVIR see related information
Date Initiated by Firm January 22, 2024
Date Posted May 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-1754-2024
Recall Event ID 94013
510(K)Number K161345  
Product Classification System, x-ray, mobile - Product Code IZL
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.
Code Information 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.
Recalling Firm/
Manufacturer		 SEDECAL SA
PELAYA, 9 POL.
POL. IND. RIO DE JANEIRO
Algete Spain
For Additional Information Contact Devan Moser
847-394-6960 Ext. 111
Manufacturer Reason
for Recall		 Potential interference with the anti-fall system.
FDA Determined
Cause 2		 Component design/selection
Action 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.
Quantity in Commerce 636 devices
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = SEDECAL SA
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