Datex-ohmeda Inc: Warmer, Infant Radiant
Recall Summary Datex-Ohmeda is recalling certain Panda Freestanding Infant Radiant Warmers that have a specific blender component installed during recent maintenance. The blender knob shaft on this component can loosen, causing the warmer to deliver oxygen at a concentration different from what the operator set, which could result in too little or too much oxygen being delivered to the patient. This recall affects only units with the specific service blender (M1091607-R) that was installed during the last preventative maintenance.
- Recalling firm
- Datex-Ohmeda Inc
- Product
- Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
- Reason
- Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-08
- Status
- Open, Classified
- Distribution
- Pending
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ed1213cd-2169-4713-b4c3-7282b2b1d45f