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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08436046002166), received between Aug 23, 2017 and Aug 23, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (1 report).

12 FDA recall records name this device's identifier, 12 still open.

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-0245-2026 · 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-0249-2026 · 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-0244-2026 · 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-0252-2026 · 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-0284-2026 · 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-0281-2026 · 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-0247-2026 · 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-0250-2026 · 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-0285-2026 · 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-0246-2026 · 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-0251-2026 · Root cause: Device Design · Recall details · FDA record ↗

12. 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.

• MalfunctionAug 23, 2017Thermal Decomposition of Device; Unintended Movement

  THE FOLLOWING WAS REPORTED TO (B)(4) BY (B)(6): THE TECHNOLOGIST WAS DRIVING THE RADPRO MOBILE 40KW FLEX PLUS (THE "MOBILE") OFF THE ELEVATOR WHEN THE MOBILE UNIT STARTED MOVING FORWARD AND HIT ANOTHER TECHNOLOGIST, THEN RAN INTO THE ELEVATOR BEFORE STOPPING. MR. (B)(6) FURTHER REPORTED THAT THE TECHNOLOGIST THEN REPORTED SMELLING AN ELECTRICAL BURNING COMING FROM THE MOBILE. THE INJURED TECHNOLOGIST THEN REPORTED TO THE (B)(6) EMPLOYEE HEALTH DEPARTMENT TO REPORT THE INCIDENT AND INJURY. THE STATEMENTS ABOVE ARE NOT DEEMED TO BE AN ADMISSION BY (B)(4).

  Patient problems: Injury

  MAUDE report 6814241 ↗