Transonic Flow Probe recall: Software Issue
Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
Why was Transonic Flow Probe recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: HQD3FMC3763, HQD3FMC3764, HQD3FMC3765, HQD3FMC3766, HQD3FMC3767, HQD3FMC3768, HQD3FMC3769, HQD3FMC3770, HQD3FMC3771, HQD3FMC3772, HQD3FMC3773, HQD3FMC3774, HQD3FMC3775, HQD3FMC3776, HQD3FMC3777, HQD3FMC3778, HQD3FMC3779, HQD3FMC3780, HQD3FMC3781, HQD3FMC3782, HQD3FMC3783, HQD3FMC3784, HQD3FMC3785, HQD3FMC3786, HQD3FMC3787, HQD3FMC3788, HQD3FMC3789, HQD3FMC3790, HQD3FMC3791, HQD3FMC3792, HQD3FMC3793, HQD3FMC3794, HQD3FMC3795, HQD3FMC3796, HQD3FMC3797, HQD3FMC3798, HQD3FMC3799, HQD3FMC3800, HQD3FMC3801, HQD3FMC3802, HQD3FMC3803, HQD3FMC3804, HQD3FMC3805, HQD3FMC3806, HQD3FMC3807, HQD3FMC3814, HQD3FMC3815
- Product
- Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
- Recalling firm
- Transonic Systems Inc
- Quantity
- Domestic: 35 units, Foreign: 12 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)