Skip to content

SEDECAL SM-20HF-BattRecalls & reported problems

Sedecal · This mobile digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography. · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

30 other recalls cover devices cleared under the same FDA submission (K090322); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 10, 2025Open, Classified

    Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

    Z-0254-2026 · Root cause: Device Design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090322. One submission often covers many models, so check the product and lot details in each record.

  • Z-0256-2026 · Jun 10, 2025 · Open, Classified
    Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
  • Z-0273-2026 · Jun 10, 2025 · Open, Classified
    Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
  • Z-0257-2026 · Jun 10, 2025 · Open, Classified
    Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
  • Z-0268-2026 · Jun 10, 2025 · Open, Classified
    Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
  • Z-0271-2026 · Jun 10, 2025 · Open, Classified
    Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
  • Z-0279-2026 · Jun 10, 2025 · Open, Classified
    Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
  • Z-0258-2026 · Jun 10, 2025 · Open, Classified
    Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
  • Z-0275-2026 · Jun 10, 2025 · Open, Classified
    Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system
  • Z-0278-2026 · Jun 10, 2025 · Open, Classified
    Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
  • Z-0261-2026 · Jun 10, 2025 · Open, Classified
    Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
  • Z-0253-2026 · Jun 10, 2025 · Open, Classified
    Model Number 40KWMOBILE3.899, Mobile X-ray system
  • Z-0269-2026 · Jun 10, 2025 · Open, Classified
    Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
  • Z-0263-2026 · Jun 10, 2025 · Open, Classified
    Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system
  • Z-0287-2026 · Jun 10, 2025 · Open, Classified
    SM_40HF_BDC3, Mobile X-ray system
  • Z-0280-2026 · Jun 10, 2025 · Open, Classified
    Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system

…and 15 more.

Other Solid State X-Ray Imager (Flat Panel/Digital Imager) devices

All Solid State X-Ray Imager (Flat Panel/Digital Imager) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page