Hall 50 PRO7100BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854040027), received between Feb 27, 2024 and Feb 27, 2024 — classified as 1 malfunction.

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

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

Recent adverse event reports

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

• MalfunctionFeb 27, 2024Overheating of Device; Overheating of Device

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT ON (B)(6) 2024, THE PRO7100B DEVICE ¿HAS BEEN USED ONCE ONLY, AND DURING PRE-OP TESTING THE DEVICE WAS NOT WORKING AS THE DEVICE TEMPERATURE INCREASED¿. THERE WAS NO REPORT OF INJURY, MEDICAL SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787411 ↗