FDA Device recall Z-1712-2019
Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat
- FDA Device
- Class II
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat by Flowonix Medical, citing 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 softwa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1712-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-21 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Flowonix Medical |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: A15E0017 A15J0019 A16D0004 RA17B0003 RA17I0001 RA18B0008 RA18D0046 RA18G0074 RA18J0074 A15…Serial Numbers: A15E0017 A15J0019 A16D0004 RA17B0003 RA17I0001 RA18B0008 RA18D0046 RA18G0074 RA18J0074 A15E0023 A15J0035 A16D0013 RA17B0004 RA17I0002 RA18B0009 RA18D0047 RA18G0079 RA18J0077 A15E0032 A15J0038 A16D0015 RA17B0007 RA17I0003 RA18B0012 RA18D0048 RA18G0080 RA18J0078 A15H0003 A15J0047 A16D0018 RA17C0001 RA17I0004 RA18B0014 RA18D0052 RA18J0001 RA18J0081 A15H0007 A15J0050 A16D0026 RA17C0005 RA17I0005 RA18B0016 RA18D0053 RA18J0002 RA18J050 A15H0031 A15J0051 A16D0032 RA17C0006 RA17I0007 RA18B0018 RA18G0004 RA18J0003 RA18K0003 A15H0038 A15K0018 A16D0033 RA17C0007 RA17I0008 RA18B0020 RA18G0005 RA18J0004 RA18K0004 A15H0039 A15K0036 A16D0036 RA17C0025 RA17I0010 RA18B0023 RA18G0006 RA18J0009 RA18K0007 A15H0054 A15K0042 A16D0037 RA17C0028 RA17I0012 RA18B0026 RA18G0007 RA18J0011 RA18K0008 A15H0067 A15K0045 A16D0039 RA17C0038 RA17I0021 RA18B0027 RA18G0010 RA18J0012 RA18K001 A15I0005 A15K0046 A1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1712-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.