Recall Z-1713-2019— Flowonix Medical Inc
Class II · Terminated
Class II FDA medical device recall by Flowonix Medical Inc, initiated 2019-03-21, terminated 2020-06-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.. Reason: 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..
- Recalling firm
- Flowonix Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-21
- Terminated
- 2020-06-05
- Firm location
- Mansfield, MA, United States
Product description
Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.