ORBIT GALAXY ENPOWER 641CF0304Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10878528009464), received between Jul 6, 2018 and Jul 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Stretched” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJul 6, 2018Stretched; Stretched

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7667227 ↗