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FDA Medical Device Recalls (openFDA)

GE OEC Medical Systems,Inc: MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system.

Recall number
Z-0704-06
Recalling firm
GE OEC Medical Systems,Inc
Product
MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system.
Status
Terminated
Initiated
2006-03-28
Posted
2006-09-30
Terminated
2011-07-25
Reason
Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.
Root cause
Other
Action
Consignees were notified by letter prior to 04/28/2006.
Quantity
534 units (Domestic), 125 (Intl)
Distribution
Nationwide.
Lot, serial or model codes
All MiniView 6800 systems.
510(k) numbers
["K992506"]
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

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

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