Events

Recall of Device Recall Parks Medical Dual Frequency Doppler

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Parks Medical Electronics Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45800
  • Event Risk Class
    Class 3
  • Event Number
    Z-0673-2008
  • Event Initiated Date
    2007-11-08
  • Event Date Posted
    2008-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67032
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ultrasonic Doppler Flow Detector - Product Code DPW
  • Reason
    Premature battery failure: wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter.
  • 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.

Device

Device Recall Parks Medical Dual Frequency Doppler
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, Brazil, Australia, and Canada
  • Product Description
    Parks Medical Dual Frequency Doppler Vascular Flow Detector, Model 915-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
  • Manufacturer
    Parks Medical Electronics Inc

Manufacturer

Parks Medical Electronics Inc
  • Manufacturer Address
    Parks Medical Electronics Inc, 19460 Sw Shaw St, Aloha OR 97007-1242
  • Manufacturer Parent Company (2017)
    Parks Medical Electronics Inc
  • Source
    USFDA