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U.S. Department of Health and Human Services

Class 3 Device Recall Parks Medical Ultrasonic Doppler Flow Detector

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  Class 3 Device Recall Parks Medical Ultrasonic Doppler Flow Detector see related information
Date Initiated by Firm November 08, 2007
Date Posted July 03, 2008
Recall Status1 Terminated 3 on October 13, 2011
Recall Number Z-0670-2008
Recall Event ID 45800
Product Classification Ultrasonic Doppler Flow Detector - Product Code DPW
Product Parks Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
Code Information Model 811-B Serial Numbers: 811B-600001876, 811B-600001877, 811B-600001878, 811B-600001879, 811B-600001880, 811B-600001882, 811B-600001883, 811B-600001884 (distributed to Australia); 811B-600001774, 811B-600001775, 811B-600001776, 811B-600001881, 811B-600002008, 811B-600002009, 811B-600002044 (distributed to Canada); 811B-600001762, 811B-600001763, 811B-600001764, 811B-600001765, 811B-600001766, 811B-600001767, 811B-600001768, 811B-600001769, 811B-600001770, 811B-600001771, 811B-600001772, 811B-600001773, 811B-600001777, 811B-600001793, 811B-600001794, 811B-600001795, 811B-600001796, 811B-600001797, 811B-600001798, 811B-600001799, 811B-600001803, 811B-600001804, 811B-600001818, 811B-600001819, 811B-600001820, 811B-600001821, 811B-600001822, 811B-600001823, 811B-600001824, 811B-600001825, 811B-600001826, 811B-600001852, 811B-600001853, 811B-600001854, 811B-600001855, 811B-600001856, 811B-600001857, 811B-600001858, 811B-600001859, 811B-600001860, 811B-600001861, 811B-600001862, 811B-600001863, 811B-600001864, 811B-600001865, 811B-600001866, 811B-600001867, 811B-600001868, 811B-600001870, 811B-600001886, 811B-600001888, 811B-600001889, 811B-600001896, 811B-600001897, 811B-600001898, 811B-600001899, 811B-600001900, 811B-600001901, 811B-600001910, 811B-600001911, 811B-600001912, 811B-600001926, 811B-600001930, 811B-600001955, 811B-600001956, 811B-600001959, 811B-600001960, 811B-600001961, 811B-600001962, 811B-600001974, 811B-600001975, 811B-600001976,  811B-600001981, 811B-600001997, 811B-600001998, 811B-600002005, 811B-600002006, 811B-600002007, 811B-600002010, 811B-600002011, 811B-600002012, 811B-600002013, 811B-600002014, 811B-600002015, 811B-600002016, 811B-600002017, 811B-600002018, 811B-600002019, 811B-600002022, 811B-600002023, 811B-600002024, 811B-600002025, 811B-600002026, 811B-600002027, 811B-600002028, 811B-600002029, 811B-600002030, 811B-600002031, 811B-600002036, 811B-600002037, 811B-600002038, 811B-600002039, 811B-600002040, 811B-600002041, 811B-600002042, 811B-600002043, 811B-600002044 (distributed in US)   Code Breakdown Example: 811B-600001896; 811B = the series; 6 = the version; 00 = the revision; 001896 = the unique identifier number.
Recalling Firm/
Manufacturer		 Parks Medical Electronics Inc
19460 Sw Shaw St
Aloha OR 97007-1242
For Additional Information Contact
503-649-7007
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.
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 122 units distributed to: 9 hospitals, 5 distributors, 5 veterinary clinics/hospitals, 1 veterinarian college. U.S., Canada, and Australia
Distribution Worldwide Distribution - USA, Brazil, Australia, and Canada
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.
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