| Class 2 Device Recall Transonic Flow Probe | |
Date Initiated by Firm | July 27, 2015 |
Date Posted | September 03, 2015 |
Recall Status1 |
Terminated 3 on July 18, 2016 |
Recall Number | Z-2728-2015 |
Recall Event ID |
71907 |
510(K)Number | K872048 |
Product Classification |
Flowmeter, blood, cardiovascular - Product Code DPW
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Product | Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage:
to measure flow intra-operatively. |
Code Information |
Serial Numbers: HQD4FMC3504, HQD4FMC3505, HQD4FMC3506, HQD4FMC3507, HQD4FMC3508, HQD4FMC3509, HQD4FMC3510, HQD4FMC3511, HQD4FMC3512, HQD4FMC3513, HQD4FMC3514, HQD4FMC3515, HQD4FMC3516, HQD4FMC3517, HQD4FMC3518, HQD4FMC3519, HQD4FMC3520 |
Recalling Firm/ Manufacturer |
Transonic Systems Inc 34 Dutch Mill Rd Ithaca NY 14850-9785
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For Additional Information Contact | Mr. David Klementowski 607-257-5300 |
Manufacturer 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 2 | 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 in Commerce | Domestic: 15 units, Foreign: 2 units |
Distribution | Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DPW
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