Recall Z-2726-2015 ยท DPW Flowmeter, Blood, Cardiovascular
Transonic Systems Inc
Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
| Date | Sep 3, 2015 (initiated Jul 27, 2015) |
| 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. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Transonic sent an Urgent Medical Device Recall letters and Response Forms dated July 27, 2015 to customers via Certified Mail, email and/or fax. The letter identified the affected product, problem and actions to be taken. Customers are instructed to contact Transonic Systems' Customer Service at 1-800-353-3569 or 1-607-257-5300 to arrange for replacement (repair/exchange) immediately. |
| Quantity | Domestic: 8 units, foreign: 11 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K872048 | TRANSONIC FLOWMETER Transonic Systems, Inc., Jun 21, 1988 |