Z-1754-2024Class II

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

Name: Z-1754-2024 Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b...
Creator: Sedecal Sa
Published: 2024-01-22
License: https://open.fda.gov/license/

Sedecal S.A. / initiated 2024-01-22 / Open, Classified / root cause: design

FDA source

SEDECAL SA began a recall of 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... on 2024-01-22. FDA classified it as Class II and gives the reason as "Potential interference with the anti-fall system". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1754-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-22
Posted: 2024-05-02
Recalling firm: Sedecal S.A.
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.
Product code: IZL System, X-Ray, Mobile
Reason for recall: Potential interference with the anti-fall system.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1754-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1754-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-05-02

Product code IZL

K161345Class IIRadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. / cleared 2016-07-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)