Baxter recalls Prismaflex 7.20 US control units with product code 955542 due to potential firmware failure causing device inoperability. Affected units may require firmware update to prevent voltage issues.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
Baxter is recalling Prismaflex 7.20 US control units (product code 955542) that may have a firmware issue causing the device to become inoperable. This could happen if the unit shows a 'Voltage Out of Range' alarm and needs servicing.
The firmware issue may cause the device to enter a safe state and become inoperable after showing a 'Voltage Out of Range' alarm. This could disrupt treatment for patients requiring renal therapy or plasma exchange.
Patients receiving continuous renal replacement therapy or therapeutic plasma exchange using the Prismaflex control unit are affected. Healthcare providers using this device for treatments in patients weighing 20kg or more are most at risk.
Check for the product code 955542 on the Prismaflex 7.20 US control unit. The device is intended for continuous renal replacement therapy or therapeutic plasma exchange in patients weighing 20 kilograms or more.
Verify the firmware version on your Prismaflex control unit to determine if it needs updating.
Reach out to Baxter Healthcare Corporation for firmware update instructions or assistance.
No, this recall specifically affects Prismaflex 7.20 US units with product code 955542.
The unit will enter a safe state and become inoperable; contact Baxter for firmware updates to prevent this issue.
The recall states the issue may cause inoperability but does not mention serious injury risks.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1926-2018 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1926-2018 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
