Reported Dec 4, 2024 · Ongoing
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
LivaNova Deutschland GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LivaNova Deutschland GmbH · Lindberghstr. 25 · Munich · N/A
Is this the product you have?
- Essenz HLM (Heart-Lung Machine)
- REF49-00-10, with Software
- Lot codes and dates
- UDI-DI04033817903062
- Software Version1.5
- Serial Numbers
49PK0043649PK0010849PK0037449PK0047949PK0048049PK0048149PK0009349PK0009149PK0009249PK0016349PK0049749PK0049849PK0021949PK0022349PK0022449PK0022549PK0022649PK0024149PK0025549PK0029249PK0029149PK0029349PK0049049PK0048749PK0048849PK0027849PK0027449PK0027749PK0027549PK0027649PK0027349PK0045749PK0045849PK0045949PK0045549PK0045649PK0029049PK00288
- Amount recalled
- 38
Where it was sold
Why it was recalled
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 gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.
This product could cause temporary or reversible health problems — stop using it.
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