FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
- Recall number
- Z-0852-2007
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
- Status
- Terminated
- Initiated
- 2007-06-12
- Posted
- 2007-06-30
- Terminated
- 2011-11-01
- Reason
- X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
- Root cause
- Other
- Action
- Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems.
- Quantity
- 25 units
- Distribution
- Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the UK.
- Lot, serial or model codes
- Serial numbers: P4-0665-R, P4-0666-L, P4-0679-R, P4-0685-L, P4-0686-L, P4-0694-R, P4-0696-L, P4-0701-R, P4-0702-R, P4-0717-L, P4-0723-R, P4-0730-L, P6-0695-R, P6-0699-R, P6-0700-R, P6-0709-R, P6-0711-L, P6-0712-R, P6-0714-L, P6-0715-L, P6-0718-R, P6-0719-L, P6-0721-L, P6-0724-R, P6-0726-L.
- 510(k) numbers
- ["K993687"]
- 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