Abiomed, Inc. — Class II: Automated Impella Controller (AIC) with the below product descriptions and corresponding P
Abiomed, Inc. is conducting a Class II recall for the Automated Impella Controller (AIC) due to retrospective reports of firmware and software defects. Identified issues include inaccuracies in the optical bench firmware (V2.19) affecting pressure signals and software defects leading to unresponsive start keys and false alarms.
Abiomed, Inc. and clinical facilities utilizing the Automated Impella Controller (AIC) in US, EU, UK, and CA markets. This impacts personnel involved in device maintenance, software configuration, and clinical monitoring.
This recall highlights the criticality of signal stability in automated controllers where clinical performance depends on accurate pressure and placement data. The retrospective nature of the report suggests that regulatory bodies may scrutinize historical data for unresolved software anomalies. Failure to address firmware defects could lead to unreliable monitoring or impaired device initiation during critical clinical procedures.
QA and engineering teams should review retrospective data for potential software or firmware defects that may impact signal integrity. Ensure all legacy systems are updated to current firmware versions (e.g., beyond V2.19) and verify that software patches effectively resolve issues related to unresponsive soft keys and false alarms.
Class II. Reason: Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.. Product: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 7. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.. Firm: Abiomed, Inc. (Danvers MA United States). Status: Ongoing.
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