Class II — Transonic Systems Inc
| Recalling firm | TRANSONIC SYSTEMS, INC. |
|---|---|
| Registered facility | TRANSONIC SYSTEMS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively. |
| Quantity | Domestic: 36 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands. |
| Initiated | 2015-07-27 |
| Classified | 2015-09-02 |
| Terminated | 2016-07-18 |
| Recall number | Z-2721-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Transonic Systems Inc (Z-2721-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71907/
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