BIS DL186-1046Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521170261), received between Jan 27, 2021 and Jan 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

1 other recall cover devices cleared under the same FDA submission (K072286); 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 16, 2026.

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.

• MalfunctionJan 27, 2021Device Damaged Prior to Use; Temperature Problem; Device Damaged Prior to Use; Temperature Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT BLEW OUT SMOKE WHEN DOING THE LEAK TEST. THE UNIT'S FRONT BEZEL WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11238159 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072286. One submission often covers many models, so check the product and lot details in each record.

• Z-2958-2018 · Jul 26, 2018 · Open, Classified
  Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319