FDAFDA · Food and drugs·Recall number Z-1754-2024
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.
Published May 8, 2024 · Recall initiated: January 22, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential interference with the anti-fall system.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SEDECAL SA
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Spain
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