# FDA recall Z-1712-2019

> **Flowonix Medical Inc** · Class II · device recall initiated 2019-03-21.

## Product

Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps.  For intrathecal infusion.

## Reason for 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.

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-1712-2019
- **Recalling firm:** Flowonix Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-21
- **Report date:** 2019-06-12
- **Termination date:** 2020-06-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1712-2019

## Citation

> AI Analytics. FDA recall Z-1712-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1712-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*