[pending] Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitati
Pending LLM rewrite. Source: FDA_DEVICE Z-2358-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
- Manufacturer
- Datex-Ohmeda Inc
- Category
- Medical Device — Devices
Distribution
Distribution scope not specified by the agency.
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