TANDEM LIFE recalls LIFESPARC Controller models 5900-0000 and 5900-0001 due to critical software freezing that may cause data loss. Affected units have specific serial numbers listed in the recall notice.
Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
TANDEM LIFE is recalling two specific models of LIFESPARC controllers (5900-0000 and 5900-0001) because their software can freeze or crash, leading to the screen not displaying data. This could disrupt critical medical monitoring for patients using circulatory or cardiopulmonary bypass systems.
The controller's software can freeze or crash, causing the screen to stop displaying data. This could lead to loss of critical monitoring information for patients undergoing circulatory or cardiopulmonary bypass procedures, potentially affecting treatment safety.
Patients using circulatory or cardiopulmonary bypass systems with the specific controller models and serial numbers listed in the recall notice are most at risk. Medical professionals who use these controllers in hospital settings may also be affected.
Check for the model numbers 5900-0000 (with UDI-DI: 00814112020562) or 5900-0001 (with UDI-DI: 00814112020623) on the device. Affected units have specific serial numbers listed in the recall notice.
Identify if your controller is model 5900-0000 or 5900-0001 with the specified UDI-DI numbers.
Confirm your controller's serial number is in the list provided in the recall notice.
This recall applies to specific LIFESPARC controllers used in circulatory or cardiopulmonary bypass systems. If your device matches the model and serial numbers listed, it is affected.
The recall does not specify a remedy, so contact TANDEM LIFE directly to confirm if your device is affected and get guidance on next steps.
Check the model number and UDI-DI on the device. Affected units are model 5900-0000 (UDI-DI: 00814112020562) or 5900-0001 (UDI-DI: 00814112020623) with specific serial numbers listed in the recall notice.
We’ve drafted a message you can send TANDEM LIFE to request your refund or repair — edit it as you like.
Subject: Recall Z-1763-2022 — TANDEM LIFE TANDEM LIFE Hello, I own a TANDEM LIFE that is covered by recall Z-1763-2022 from TANDEM LIFE. 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.
