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FDA Medical Device Recalls (openFDA)

GE OEC Medical Systems,Inc: Uroview 2500 X-ray System

Recall number
Z-0946-03
Recalling firm
GE OEC Medical Systems,Inc
Product
Uroview 2500 X-ray System
Status
Terminated
Initiated
2003-05-12
Posted
2003-06-21
Terminated
2011-07-07
Reason
Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.
Root cause
Other
Action
A Product Safety Alert letter was sent to all consignees on 5/12/2003 recommending that all hand controls be removed from the units.
Quantity
263 units
Distribution
Nationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland.
Lot, serial or model codes
Serial numbers beginning with M2 and M9.
510(k) numbers
["K914446"]
PMA numbers
not on file
Product code
JAA
Firm FEI
1720753
Firm city
Salt Lake City
Firm state
UT
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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