SEDECAL SM-40HF-B-D-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08436046001510), received between Feb 13, 2018 and Feb 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

24 FDA recall records name this device's identifier, 24 still open.

9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 10, 2025Class IIOpen, 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-0258-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Jun 10, 2025Class IIOpen, 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-0271-2026 · Root cause: Device Design · Recall details · FDA record ↗

3. Jun 10, 2025Class IIOpen, 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-0273-2026 · Root cause: Device Design · Recall details · FDA record ↗

4. Jun 10, 2025Class IIOpen, 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-0277-2026 · Root cause: Device Design · Recall details · FDA record ↗

5. Jun 10, 2025Class IIOpen, 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-0287-2026 · Root cause: Device Design · Recall details · FDA record ↗

6. Jun 10, 2025Class IIOpen, 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-0268-2026 · Root cause: Device Design · Recall details · FDA record ↗

7. Jun 10, 2025Class IIOpen, 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-0266-2026 · Root cause: Device Design · Recall details · FDA record ↗

8. Jun 10, 2025Class IIOpen, 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-0274-2026 · Root cause: Device Design · Recall details · FDA record ↗

9. Jun 10, 2025Class IIOpen, 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-0257-2026 · Root cause: Device Design · Recall details · FDA record ↗

10. Jun 10, 2025Class IIOpen, 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-0286-2026 · Root cause: Device Design · Recall details · FDA record ↗

11. Jun 10, 2025Class IIOpen, 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-0260-2026 · Root cause: Device Design · Recall details · FDA record ↗

12. Jun 10, 2025Class IIOpen, 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-0269-2026 · Root cause: Device Design · Recall details · FDA record ↗

13. Jun 10, 2025Class IIOpen, 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-0263-2026 · Root cause: Device Design · Recall details · FDA record ↗

14. Jun 10, 2025Class IIOpen, 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-0267-2026 · Root cause: Device Design · Recall details · FDA record ↗

15. Jun 10, 2025Class IIOpen, 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-0278-2026 · Root cause: Device Design · Recall details · FDA record ↗

16. Jun 10, 2025Class IIOpen, 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-0280-2026 · Root cause: Device Design · Recall details · FDA record ↗

17. Jun 10, 2025Class IIOpen, 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-0270-2026 · Root cause: Device Design · Recall details · FDA record ↗

18. Jun 10, 2025Class IIOpen, 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-0272-2026 · Root cause: Device Design · Recall details · FDA record ↗

19. Jun 10, 2025Class IIOpen, 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-0265-2026 · Root cause: Device Design · Recall details · FDA record ↗

20. Jun 10, 2025Class IIOpen, 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-0259-2026 · Root cause: Device Design · Recall details · FDA record ↗

21. Jun 10, 2025Class IIOpen, 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-0275-2026 · Root cause: Device Design · Recall details · FDA record ↗

22. Jun 10, 2025Class IIOpen, 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-0276-2026 · Root cause: Device Design · Recall details · FDA record ↗

23. Jun 10, 2025Class IIOpen, 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-0279-2026 · Root cause: Device Design · Recall details · FDA record ↗

24. Jan 22, 2024Class IIOpen, Classified

    Potential interference with the anti-fall system.

    Z-1754-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2018Mechanical Problem; Unintended Movement

  THE FOLLOWING WAS REPORTED TO VIRTUAL IMAGING, INC. BY (B)(6) OF (B)(6) ON (B)(6) 2018: ON (B)(6) 2018, (B)(6) (RADIOGRAPHIC TECHNOLOGIST) WAS DRIVING A RADPRO MOBILE 40 KW DIGITAL X-RAY SYSTEM (THE "UNIT") DOWN A HALLWAY BY THE CAFETERIA IN (B)(6) . (B)(6) DROVE THE UNIT OVER A METAL THRESHOLD, AND THE UNIT BEGAN PULLING TO THE LEFT AND DRIVING IN A CIRCLE. THE UNIT DROVE ONTO (B)(6)'S FOOT AND BENT HIS LEG INWARD, CAUSING KNEE PAIN. AT THIS TIME (B)(6) HIT THE EMERGENCY STOP BUTTON. UPON RESTARTING, THE UNIT WAS DRIVEN BACK TO THE MAIN DEPARTMENT OF (B)(6) WITHOUT ANY COMPLICATIONS. (B)(6) DID NOT SEEK MEDICAL HELP.

  Patient problems: Pain

  MAUDE report 7267939 ↗

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-0261-2026 · Jun 10, 2025 · Open, Classified
  Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
• Z-0283-2026 · Jun 10, 2025 · Open, Classified
  SHIMADZU RF.004, Mobile X-ray system
• Z-0255-2026 · Jun 10, 2025 · Open, Classified
  Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
• Z-0262-2026 · Jun 10, 2025 · Open, Classified
  Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
• Z-0282-2026 · Jun 10, 2025 · Open, Classified
  SED URS LP, Mobile X-ray system
• Z-0254-2026 · Jun 10, 2025 · Open, Classified
  Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
• Z-0253-2026 · Jun 10, 2025 · Open, Classified
  Model Number 40KWMOBILE3.899, Mobile X-ray system
• Z-0264-2026 · Jun 10, 2025 · Open, Classified
  Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
• Z-0256-2026 · Jun 10, 2025 · Open, Classified
  Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system