FDA Medical Device Recalls (openFDA)
Parks Medical Electronics Inc: Parks Medical Ultrasonic Doppler Flow Detector, Model 811-BTS (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
- Recall number
- Z-0672-2008
- Recalling firm
- Parks Medical Electronics Inc
- Product
- Parks Medical Ultrasonic Doppler Flow Detector, Model 811-BTS (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
- Status
- Terminated
- Initiated
- 2007-11-08
- Posted
- 2008-07-03
- Terminated
- 2011-10-13
- Reason
- 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
- 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
- 34 units distributed to: 14 hospitals, 2 veterinary clinics/hospitals, 1 U.S. distributor. No foreign or gov't consignees.
- Distribution
- Worldwide Distribution - USA, Brazil, Australia, and Canada
- Lot, serial or model codes
- Model 811-BTS. Serial numbers: 811B-700001209, 811B-700001210, 811B-700001211, 811B-700001212, 811B-700001214, 811B-700001215, 811B-700001216, 811B-700001217, 811B-700001218, 811B-700001252, 811B-700001253, 811B-700001254, 811B-700001255, 811B-700001256, 811B-700001257, 811B-700001258, 811B-700001259, 811B-700001260, 811B-700001261, 811B-700001262, 811B-700001263, 811B-700001264, 811B-700001265, 811B-700001266, 811B-700001268, 811B-700001269, 811B-700001273, 811B-700001274, 811B-700001276, 811B-700001277, 811B-700001278, 811B-700001279, 811B-700001282, 811B-700001288
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DPW
- Firm FEI
- 3020115
- Firm city
- Aloha
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28