The FDA has issued a Class 1 recall for GE Healthcare's Giraffe and Panda T-Piece Resuscitation Systems and mask resuscitation systems after an assembly reversal was discovered, according to the American Society of Anesthesiologists.
The systems are designed to provide pulmonary resuscitation for infants, but the affected products may have reversed oxygen and air wall inlet fittings. This issue could reverse the oxygen concentrations and render the settings inaccurate. The product may have adverse health consequences, including death.
GE recommended that biomedical technicians or respiratory therapists check the systems and verify if the air fitting is properly installed. All affected units will need repairs.
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The systems are designed to provide pulmonary resuscitation for infants, but the affected products may have reversed oxygen and air wall inlet fittings. This issue could reverse the oxygen concentrations and render the settings inaccurate. The product may have adverse health consequences, including death.
GE recommended that biomedical technicians or respiratory therapists check the systems and verify if the air fitting is properly installed. All affected units will need repairs.
More Articles on Anesthesia:
Study: Minor Procedures Produce High Pain, Not Always Well Managed
FDA Issues Notice to Hospira for Device Quality Concerns
ASA Opposes Proposed Changes to Opioid Labels by FDA