Recall Z-2723-2015
Transonic Systems Inc · initiated July 27, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
Codes / lots: Serial Numbers: HQC8FMV2142, HQC8FMV2143, HQC8FMV2144, HQC8FMV2145, HQC8FMV2146
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.
FDA-determined cause: Software Manufacturing/Software Deployment
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.
Details
- Recall number
- Z-2723-2015
- Initiated
- July 27, 2015
- Posted by FDA
- September 3, 2015
- Terminated
- July 18, 2016
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Quantity
- Domestic: 5 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
- Recalling firm
- Transonic Systems Inc, Ithaca, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2720-2015 Class II | Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2721-2015 Class II | Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2722-2015 Class II | Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2724-2015 Class II | Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2725-2015 Class II | Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2726-2015 Class II | Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2727-2015 Class II | Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2728-2015 Class II | Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2729-2015 Class II | Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |