Flowonix recalls Prometra Programmer software version 2.00.29 (Cat. No. 13828) used with Prometra pumps due to unexpected shutdowns when error 115 occurs, which can happen during specific infusion programming.
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.
Flowonix is recalling a specific software version for their Prometra Programmer used with medical pumps. This software version can shut down unexpectedly if a certain error occurs during programming, which could lead to interrupted medication delivery.
The software defect causes the pump to shut down unexpectedly when a specific error (Error 115) is triggered. This error happens when a healthcare provider uses the Clinician Programmer software version 2.00.29 to program a Bridge or Demand bolus while the pump is set to Periodic Flow or Multiple Rates mode.
Healthcare providers who use the Prometra Programmer software version 2.00.29 with Prometra or Prometra II pumps are affected. Those programming intrathecal infusions are at higher risk.
Check if your Prometra Programmer has software version 2.00.29 (Cat. No. 13828) with serial numbers listed in the recall notice. This software is used with Prometra and Prometra II programmable pumps for intrathecal infusions.
Verify your Prometra Programmer software version by checking the device settings or documentation. The affected version is 2.00.29 (Cat. No. 13828).
Contact Flowonix Medical Inc to get the updated software version that fixes the error. They will provide instructions for updating.
Error 115, an alarm associated with a watchdog timer timeout, occurs when programming a Bridge or Demand bolus while the pump is set to Periodic Flow or Multiple Rates mode.
Prometra and Prometra II programmable pumps that use the Prometra Programmer software version 2.00.29 (Cat. No. 13828).
Check the serial numbers listed in the recall notice: D18L0003 through D18L0042.
We’ve drafted a message you can send Flowonix to request your refund or repair — edit it as you like.
Subject: Recall Z-1713-2019 — Flowonix Flowonix Hello, I own a Flowonix that is covered by recall Z-1713-2019 from Flowonix. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
