Essenz HLM Heart-Lung Machines May Fail Due to Software Defect
The recalled Essenz HLM heart-lung machines (38 units) may experience GUI display failures and sensor deactivation. This can lead to hypoxia and hypoperfusion.
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: This is an FDA Class II recall of a critical medical device with serious potential hazards (hypoxia and hypoperfusion). No illnesses or injuries are reported in the source material. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
LivaNova Deutschland GmbH is recalling 38 Essenz HLM (Heart-Lung Machine) devices (REF 49-00-10, Software Version 1.5) distributed nationwide in California, Virginia, Georgia, Indiana, New Jersey, Florida, Colorado, Mississippi, and Nevada.
The affected devices may experience a GUI touchscreen display failure where the screen goes dark for 10-15 seconds during operation. While the device's safety and performance functions remain operational during this period, control can be maintained through a backup control panel. However, a second reset may occur, which can cause the gas blender to enter standby mode. When this occurs, the gas blender must be manually reactivated through the device's user interface, and sensors become deactivated until a new case is started. These cascading failures can lead to hypoxia (inadequate oxygen delivery to tissues) and hypoperfusion (inadequate blood circulation).
Affected facilities with any of the specified serial numbers should contact LivaNova for repair or replacement instructions and should not operate the affected devices until they have been serviced.
The recalled product
- Product
- Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
- Manufacturer
- LivaNova Deutschland GmbH
- Affected units
- 38
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 04033817903062. Software Version: 1.5. Serial Numbers: 49PK00436
- 49PK00108
- 49PK00374
- 49PK00479
- 49PK00480
- 49PK00481
- 49PK00093
- 49PK00091
- 49PK00092
- 49PK00163
- 49PK00497
- 49PK00498
- 49PK00219
- 49PK00223
- 49PK00224
- 49PK00225
- 49PK00226
- 49PK00241
- 49PK00255
- 49PK00292
Distribution
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