Flowmeter, Blood, Cardiovascular

Brand Name: BiDop 3

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Brand Name: Medistim MiraQ System

Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.

FloPatch FP120, REF: FP120-FOT01-005

Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.

GEM FLOW COUPLER Monitor, PN 5156-00000-011

An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.

Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC

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.

Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC --

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.

Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV --

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.

Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV --

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.

Transonic Flow Probe, 2 mm, Catalog Number HQC2MP --

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.

Transonic Flow Probe, 3 mm, Catalog Number HQC3MP --

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.