Z-0671-2008

Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly...

Name: Z-0671-2008 Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly...
Creator: Parks Medical Electronics Inc
Published: 2007-11-08
License: https://open.fda.gov/license/

Parks Medical Electronics Inc / initiated 2007-11-08 / Terminated / root cause: manufacturing process

FDA source

Parks Medical Electronics Inc began a recall of Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly without accompanying probes), Parks Medical... on 2007-11-08. The reason FDA records is "Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0671-2008
Status: Terminated
Initiated: 2007-11-08
Posted: 2008-07-03
Terminated: 2011-10-13
Recalling firm: Parks Medical Electronics Inc
Product: Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
Product code: DPW Flowmeter, Blood, Cardiovascular
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.
Root cause tag: manufacturing process
FDA root cause: 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: 1 unit distributed to: Canadian veterinarian hospital on 9/26/07
Distribution: Worldwide Distribution - USA, Brazil, Australia, and Canada
Product codes and lots: Model 811-BL. Serial Number: 811-B-400001438

Product code DPW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)