MasimoSET® rainbow RC-4 rainbow® Patient Cable 2406Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843997002295), received between Jul 7, 2017 and Sep 15, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Stops Intermittently” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K080238); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED INTERMITTENTLY THE CABLE WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES WITH NO ERROR MESSAGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6867801 ↗
• MalfunctionAug 29, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED INTERMITTENTLY WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES WITH NO ERROR MESSAGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6826271 ↗
• MalfunctionAug 12, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED INTERMITTENTLY WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES WITH NO ERRORS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6790853 ↗
• MalfunctionJul 21, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED THE CABLE INTERMITTENTLY WOULD DISPLAY VALUES THEN SUDDENLY DISPLAY NO VALUES WITH NO ERROR MESSAGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6731060 ↗
• MalfunctionJul 7, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED SENSOR'S LED TURNED OFF WITHOUT PROVIDING AN ERROR MESSAGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6692237 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080238. One submission often covers many models, so check the product and lot details in each record.

• Z-0338-2016 · Oct 28, 2015 · Terminated
  rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW