Giraffe Stand-alone Infant Resuscitation System T-pieceRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840682100151), received between Feb 10, 2025 and Mar 11, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K070210); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING SERVICE RESULTING IN OXYGEN THERAPY UNAVAILABILITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567319 ↗
• MalfunctionFeb 10, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343701 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070210. One submission often covers many models, so check the product and lot details in each record.

• Z-0916-2014 · Dec 12, 2013 · Terminated
  Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M12414
• Z-0917-2014 · Dec 12, 2013 · Terminated
  Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Pr
• Z-1070-2014 · Oct 1, 2013 · Terminated
  GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emerg
• Z-0748-2013 · Oct 15, 2012 · Terminated
  GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation Syste
• Z-0606-2013 · Jun 26, 2012 · Terminated
  GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10