LivaNova Deutschland GmbH recalls Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to…
Read the official notice →- Date
- 2024-12-04
- Country
- United States
- Brand
- LivaNova Deutschland
- Product
- Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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