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Class 3 Device Recall Parks Medical Dual Frequency Doppler |
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Date Initiated by Firm |
November 08, 2007 |
Date Posted |
July 03, 2008 |
Recall Status1 |
Terminated 3 on October 13, 2011 |
Recall Number |
Z-0673-2008 |
Recall Event ID |
45800 |
Product Classification |
Ultrasonic Doppler Flow Detector - Product Code DPW
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Product |
Parks Medical Dual Frequency Doppler Vascular Flow Detector, Model 915-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007 |
Code Information |
Model 915-BL. Serial Numbers: 915B-000001329, 915B-000001330, 915B-000001331, 915B-000001332 Code Breakdown Example: 915B-000001329; 915B = the final assembly of series 915-BL; 0 = the version; 00 = the revision; 001329 = the unique identifier number. |
Recalling Firm/ Manufacturer |
Parks Medical Electronics Inc 19460 Sw Shaw St Aloha OR 97007-1242
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For Additional Information Contact |
503-649-7007
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Manufacturer Reason for Recall |
Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter.
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FDA Determined Cause 2 |
Process control |
Action |
811-B: On 9/28/07 Parks Medical Electronics notified their related U.S. distributor, Parks Medical Electronics Sales, Inc., Las Vegas, NV by email instructing them to stop further shipments. On 10/1/07 firm followed up with phone call instructing all units be returned for rework. On 11/8/07 firm sent replacement units accompanied with a Warranty Exchange Letter to their other U.S. customers notifying them of affected units. Letters were customized for each customer with a fill-in-the-blank of the model and serial numbers. Letters and replacement units were sent UPS 2nd Day Air and informed customer about the assembly error and instructions for returning the defective units. On 11/8/07 emails were sent to Brazilian and Australian distributors informing about assembly error and affected units. Rework instructions and a schematic were provided by email for each distributor to perform their own rework. On 11/28/97 Canadian customers were sent Warranty Exchange Letters and replacement units via UPS Ground.
Firm is retrieving units from US and Canadian firms and will rework them. Firm is waiting to hear whether Brazilian or Austraian distributors need to sub-recall. Canadian distributors instructed to conduct subrecall if needed.
All returned units will be reworked by disassembly of unit, removal of affected printed circuit board, washing board to remove acid flux, and testing. |
Quantity in Commerce |
4 units distributed to 1 U.S. hospital |
Distribution |
Worldwide Distribution - USA, Brazil, Australia, and Canada |
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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