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U.S. Department of Health and Human Services

Class 2 Device Recall Transonic Flow Probe

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  Class 2 Device Recall Transonic Flow Probe see related information
Date Initiated by Firm July 27, 2015
Date Posted September 03, 2015
Recall Status1 Terminated 3 on July 18, 2016
Recall Number Z-2721-2015
Recall Event ID 71907
510(K)Number K872048  
Product Classification Flowmeter, blood, cardiovascular - Product Code DPW
Product Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC --

Product Usage:
to measure flow intra-operatively.
Code Information Serial Numbers: HQC3FMC2501, HQC3FMC2502, HQC3FMC2503, HQC3FMC2504, HQC3FMC2505, HQC3FMC2506, HQC3FMC2507, HQC3FMC2508, HQC3FMC2509, HQC3FMC2510, HQC3FMC2511, HQC3FMC2512, HQC3FMC2513, HQC3FMC2514, HQC3FMC2515, HQC3FMC2516, HQC3FMC2517, HQC3FMC2518, HQC3FMC2519, HQC3FMC2520, HQC3FMC2521, HQC3FMC2522, HQC3FMC2523, HQC3FMC2524, HQC3FMC2525, HQC3FMC2526, HQC3FMC2527, HQC3FMC2528, HQC3FMC2529, HQC3FMC2530, HQC3FMC2531, HQC3FMC2532, HQC3FMC2533, HQC3FMC2534, HQC3FMC2535, HQC3FMC2636
Recalling Firm/
Manufacturer		 Transonic Systems Inc
34 Dutch Mill Rd
Ithaca NY 14850-9785
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: 36 units
Distribution Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = DPW and Original Applicant = TRANSONIC SYSTEMS, INC.
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