Flowonix recalls Prometra Clinician Programmer software version 2.00.29 (Cat. No. 12828) due to unexpected shutdowns when programming certain bolus types. Affected units have specific serial numbers listed in the recall.
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 Clinician Programmer touchscreen device. The software can shut down unexpectedly when a healthcare provider programs a Bridge or Demand bolus while the pump is set to Periodic Flow or Multiple Rates mode. This could lead to treatment interruptions.
The software defect causes the pump to shut down unexpectedly when Error 115 (a watchdog timer timeout) is triggered. This happens when a healthcare provider programs a Bridge or Demand bolus while the pump is set to Periodic Flow or Multiple Rates flow mode, potentially interrupting treatment.
Healthcare providers using the Prometra Clinician Programmer software version 2.00.29 with Prometra or Prometra II programmable pumps are affected. Those programming bolus doses while the pump is in Periodic Flow or Multiple Rates mode are at risk of unexpected shutdowns.
Check if your Prometra Clinician Programmer has software version 2.00.29 (Cat. No. 12828). Affected units have specific serial numbers listed in the recall notice.
Verify your Prometra Clinician Programmer software version is 2.00.29 (Cat. No. 12828).
Update to a newer software version if available through the manufacturer.
Software version 2.00.29 (Cat. No. 12828) for Prometra Clinician Programmer.
The pump shuts down unexpectedly when Error 115 is triggered, which can occur during programming of Bridge or Demand bolus while the pump is set to Periodic Flow or Multiple Rates mode.
Check if your Prometra Clinician Programmer has software version 2.00.29 (Cat. No. 12828) and one of the listed serial numbers.
We’ve drafted a message you can send Flowonix to request your refund or repair — edit it as you like.
Subject: Recall Z-1712-2019 — Flowonix Flowonix Hello, I own a Flowonix that is covered by recall Z-1712-2019 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.
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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.
