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Class 2 Device Recall Transonic Flow Probe |
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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
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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.
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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
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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.
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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 and Original Applicant = TRANSONIC SYSTEMS, INC.
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