The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1754-2024·Announced 2024-05-08

Battery Mobile X-ray Units Recalled for Anti-Fall System Interference

SEDECAL SA is recalling 636 Battery Mobile X-ray Unit EASY MOVING models worldwide due to potential interference with the anti-fall system.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with a potential safety hazard involving the anti-fall system. No illnesses or injuries have been reported. The hazard is theoretical rather than confirmed.

Plain-English summary

SEDECAL SA is recalling 636 Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1 devices due to potential interference with the anti-fall system. The affected device models include SM-20HF-Batt, SM-32HF-Batt, SM-40HF-Batt, SM-50HF-Batt, as well as SM-40-HF-B-D-VIR, AeroDR X30 variants, and MobileDiagnost wDR models. These devices are distributed worldwide.

In the United States, devices have been distributed in California, Illinois, and New Jersey, with additional affected areas under identification. The recall is issued due to potential interference with the anti-fall system of these mobile X-ray units. No illnesses or injuries have been reported in connection with this issue.

The recalled product

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…
Manufacturer
SEDECAL SA
Category
Medical Device — Diagnostic Imaging / X-ray Equipment
Hazard
Affected units
636

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • 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.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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