Parks Medical Dual Frequency Doppler Vascular Flow Detector, Model 915-BL (finished assembly without accompanying probes

FDA device recall Z-0673-2008 · posted 2008-07-03 · Terminated

Recall details

Recalling firm

Parks Medical Electronics Inc

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

DPW

Quantity affected

4 units distributed to 1 U.S. hospital

Distribution

Worldwide Distribution - USA, Brazil, Australia, and Canada

Date initiated

2007-11-08

Date posted

2008-07-03

Date terminated

2011-10-13

Location

Aloha, OR