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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

SEDECAL SA: EASY MOVING Mobile X-ray Units Recalled for Anti-Fall System Interference

Agency Publication Date: May 2, 2024
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Summary

SEDECAL SA is recalling 636 units of the EASY MOVING Battery Mobile X-ray Units, including model 3.1 with a telescopic column, due to potential interference with the machine's anti-fall system. This interference can prevent the safety mechanism from operating correctly, which could lead to the x-ray unit or its column falling unexpectedly. Affected models include various SM-series units and the MobileDiagnost wDR, which were distributed worldwide and in the states of California, Illinois, and New Jersey. Consumers should contact their healthcare provider or the manufacturer to arrange for an inspection and necessary repairs.

Risk

Internal interference may disrupt the anti-fall system, creating a risk that the telescopic column or the mobile unit could collapse or fall. This poses a danger of impact injuries to patients or healthcare staff during medical imaging procedures.

What You Should Do

  1. Identify your device by checking the model name and UDI-DI number located on the equipment label. Affected models include SM-20HF-Batt (08436046001497), SM-32HF-Batt (08436046001503), SM-40HF-Batt (08436046001510), SM-50HF-Batt (08436046001527), SM-40-HF-B-D-VIR (08436046002166), SM-20HF-B-D-KM (08436046002579), SM-32-HF-B-D-KM (08436046002586), SM-40HF-B-D-KM (08436046002593), SM-50HF-B-D-KM (08436046002609), and MobileDiagnost wDR (08436046002357).
  2. Verify if your unit is part of the 'model 3.1 Battery Mobile X-ray Unit EASY MOVING' series, as all serial numbers for this specific model version are impacted.
  3. Immediately contact your facility's biomedical engineering department or the manufacturer, SEDECAL SA, to confirm receipt of the notification letter and schedule a service visit.
  4. Follow all instructions provided by the manufacturer regarding the safe operation of the telescopic column until the anti-fall system has been inspected and corrected.
  5. Contact your healthcare provider or SEDECAL SA for further instructions and information regarding the potential for repairs or refunds.
  6. For additional questions, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and device inspection/correction.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: Battery Mobile X-ray Unit EASY MOVING Model 3.1 SM-20HF-Batt
Model / REF:
SM-20HF-Batt
UPC Codes:
08436046001497
Lot Numbers:
All serial numbers of model 3.1
Product: Battery Mobile X-ray Unit EASY MOVING Model 3.1 SM-32HF-Batt
Model / REF:
SM-32HF-Batt
UPC Codes:
08436046001503
Lot Numbers:
All serial numbers of model 3.1
Product: Battery Mobile X-ray Unit EASY MOVING Model 3.1 SM-40HF-Batt
Model / REF:
SM-40HF-Batt
UPC Codes:
08436046001510
Lot Numbers:
All serial numbers of model 3.1
Product: Battery Mobile X-ray Unit EASY MOVING Model 3.1 SM-50HF-Batt
Model / REF:
SM-50HF-Batt
UPC Codes:
08436046001527
Lot Numbers:
All serial numbers of model 3.1
Product: Battery Mobile X-ray Unit EASY MOVING Model 3.1 SM-40-HF-B-D-VIR
Model / REF:
SM-40-HF-B-D-VIR
UPC Codes:
08436046002166
Lot Numbers:
All serial numbers of model 3.1
Product: Battery Mobile X-ray Unit EASY MOVING Model 3.1 SM-20HF-B-D-KM (AeroDR X30)
Model / REF:
SM-20HF-B-D-KM
UPC Codes:
08436046002579
Lot Numbers:
All serial numbers of model 3.1
Product: Battery Mobile X-ray Unit EASY MOVING Model 3.1 SM-32-HF-B-D-KM (AeroDR X30)
Model / REF:
SM-32-HF-B-D-KM
UPC Codes:
08436046002586
Lot Numbers:
All serial numbers of model 3.1
Product: Battery Mobile X-ray Unit EASY MOVING Model 3.1 SM-40HF-B-D-KM (AeroDR X30)
Model / REF:
SM-40HF-B-D-KM
UPC Codes:
08436046002593
Lot Numbers:
All serial numbers of model 3.1
Product: Battery Mobile X-ray Unit EASY MOVING Model 3.1 SM-50HF-B-D-KM (AeroDR X30)
Model / REF:
SM-50HF-B-D-KM
UPC Codes:
08436046002609
Lot Numbers:
All serial numbers of model 3.1
Product: Battery Mobile X-ray Unit EASY MOVING Model 3.1 MobileDiagnost wDR
Model / REF:
MobileDiagnost wDR
UPC Codes:
08436046002357
Lot Numbers:
All serial numbers of model 3.1

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94013
Status: Active
Manufacturer: SEDECAL SA
Sold By: Philips Medical Systems DMC GmbH
Manufactured In: Spain
Units Affected: 636 devices
Distributed To: California, Illinois, New Jersey

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.