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FDA Medical Device Recalls (openFDA)

Valleylab, Inc: Radionics Disposable Grounding Plate

Recall number
Z-1121-03
Recalling firm
Valleylab, Inc
Product
Radionics Disposable Grounding Plate
Status
Terminated
Initiated
2003-07-16
Posted
2003-08-12
Terminated
2004-02-18
Reason
Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
Root cause
Other
Action
Users were notified by letter on 7/16/2003.
Quantity
25000 pads
Distribution
Nationwide. VA Hospital, San Antonio, TX. Foreign distribution to Australia, Brazil, Canada, Dominican Republic, France, Germany, Hong Kong, India, Israel, Japan, Korea, Phillipines, Singapore, Taiwan.
Lot, serial or model codes
Catalog Number DGP-HP.
510(k) numbers
["K000079"]
PMA numbers
not on file
Product code
HAM
Firm FEI
1717344
Firm city
Boulder
Firm state
CO
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

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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

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