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NUERA TIGHT APMD140Recalls & reported problems

Bios Srl · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08052049500104), received between Oct 29, 2020 and Jun 2, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K151296); 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.

Most reported problems

Device problems

  • Insufficient Device Problem Information2

Patient problems

  • Burn(s)2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    LUMENIS RECEIVED A REPORT OF A PATIENT FEELING A SHOCKING SENSATION AND SUFFERED FROM A BLISTER FOLLOWING TREATMENT WITH BIOS NUERA DEVICE.

    Patient problems: Burn(s)

    MAUDE report 11920602 ↗
  • InjuryOct 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED SCABS FOLLOWING TREATMENT WITH BIOS NUERA DEVICE. NO INITIAL REPORT ON SERIOUS INJURY WAS RECEIVED. THE CUSTOMER REPORTED ON BIPOLAR HP SHOCKING SENSATION. THE SERVICE ENGINEER SUSPECTS THE MOST LIKELY CAUSE FOR THE ISSUE WITH THE GEL. THE CUSTOMER REPORTS THAT THEY HAVE USED MANY DIFFERENT FORMS OF GEL AND IT STILL SHOCKS PEOPLE.

    Patient problems: Burn(s)

    MAUDE report 10754647 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151296. One submission often covers many models, so check the product and lot details in each record.

  • Z-0052-2018 · Jul 13, 2017 · Terminated
    THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.

Other Massager, Vacuum, Radio Frequency Induced Heat devices

All Massager, Vacuum, Radio Frequency Induced Heat devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.