Transonic Systems Inc: Medical Device Recall in 2015 - (Recall #: Z-2728-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.

Product Classification:

Class II

Date Initiated: July 27, 2015

Date Posted: September 9, 2015

Recall Number: Z-2728-2015

Event ID: 71907

Reason for Recall:

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.

Status: Terminated

Product Quantity: Domestic: 15 units, Foreign: 2 units

Code Information:

Serial Numbers: HQD4FMC3504, HQD4FMC3505, HQD4FMC3506, HQD4FMC3507, HQD4FMC3508, HQD4FMC3509, HQD4FMC3510, HQD4FMC3511, HQD4FMC3512, HQD4FMC3513, HQD4FMC3514, HQD4FMC3515, HQD4FMC3516, HQD4FMC3517, HQD4FMC3518, HQD4FMC3519, HQD4FMC3520

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated