FDA Device recall Z-2728-2015
Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively by Transonic Systems, citing software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow met….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2728-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-27 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Transonic Systems |
| Distribution | US |
Product
Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.
Reason
Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
Identifiers
| code_info | Serial Numbers: HQD4FMC3504, HQD4FMC3505, HQD4FMC3506, HQD4FMC3507, HQD4FMC3508, HQD4FMC3509, HQD4FMC3510, HQD4FMC3511…Serial Numbers: HQD4FMC3504, HQD4FMC3505, HQD4FMC3506, HQD4FMC3507, HQD4FMC3508, HQD4FMC3509, HQD4FMC3510, HQD4FMC3511, HQD4FMC3512, HQD4FMC3513, HQD4FMC3514, HQD4FMC3515, HQD4FMC3516, HQD4FMC3517, HQD4FMC3518, HQD4FMC3519, HQD4FMC3520 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2728-2015%22
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