FDA Medical Device Recalls (openFDA)
Transonic Systems Inc: Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
- Recall number
- Z-2723-2015
- Recalling firm
- Transonic Systems Inc
- Product
- Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
- Status
- Terminated
- Initiated
- 2015-07-27
- Posted
- 2015-09-03
- Terminated
- 2016-07-18
- 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: 5 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
- Lot, serial or model codes
- Serial Numbers: HQC8FMV2142, HQC8FMV2143, HQC8FMV2144, HQC8FMV2145, HQC8FMV2146
- 510(k) numbers
- ["K872048"]
- PMA numbers
- not on file
- Product code
- DPW
- Firm FEI
- 1319030
- Firm city
- Ithaca
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28