FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Salt Lake City, Utah.
- Recall number
- Z-0716-2008
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Salt Lake City, Utah.
- Status
- Terminated
- Initiated
- 2007-09-28
- Posted
- 2008-03-15
- Terminated
- 2011-11-01
- Reason
- Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator.
- Root cause
- Other
- Action
- On or about 9/6/2007, by Customer Notification Letter, users were notified that all affected units will be corrected by GE personnel with the addition of an additional shield.
- Quantity
- 157 units (Domestic), 142 units (Foreign)
- Distribution
- Worldwide- USA including states of CO, DE, FL, NJ, MO, NY, PA, and TX (with VA and Military facilities) and countries of Australia, Austria, Belgium, Brazil, Chile, China, The Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Norway, Spain, Sweden, Switzerland, Thailand, and The UK.
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- ["K970063"]
- 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