Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
FDA device recall Z-2723-2015 · posted 2015-09-03 · Terminated
Recall details
- Recalling firm
- Transonic Systems Inc
- 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.
- Action taken
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Terminated
- Product code
- DPW
- Quantity affected
- Domestic: 5 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
- Date initiated
- 2015-07-27
- Date posted
- 2015-09-03
- Date terminated
- 2016-07-18
- Location
- Ithaca, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRANSONIC FLOWMETER (K872048) | Transonic Systems, Inc. | 1988-06-21 |