FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: OEC 9800 MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
- Recall number
- Z-0681-2007
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- OEC 9800 MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
- Status
- Terminated
- Initiated
- 2007-03-01
- Posted
- 2007-09-28
- Terminated
- 2012-05-01
- Reason
- During routine service, primary and/or secondary collimators may not have been properly reinstalled.
- Root cause
- Other
- Action
- Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.
- Quantity
- 70 units
- Distribution
- Nationwide and Germany.
- Lot, serial or model codes
- Serial numbers: 82-7001-MH, 82-7004-MH, 82-7006-MH, 82-7009-MH, 82-7024-MH, 82-7034-MH, 82-7077-MH, 82-7086-MH, 82-7096-MH, 82-7098-MH, 82-7105-MH, 82-7110-MH, 82-7139-MH, 82-2061-C, 82-1094-C, 82-0619-M, 89-0483-C, 8S-7031-MH, 8S-7035-MH-RC, 8S-7047-MH, 8S-7075-CMH, 8S-7127-MH, 8S-7145-MH, 8S-7164-CMH, 8S-2791-C, 8S-2518-C, 8S-2519-C, 8S-2046-C, 8S-2054-C, 8S-1911-C, 8S-1772-C, 8S-1632-C, 8S-1490-C, 8S-1449-C, 8S-1224-C-RC, 8S-1212-C, 8S-1069-C, 8S-1065-C, 8S-1013-C, 8S-0849-C, 8S-0793-C, 8S-0790-C, 8S-0754-C, 8S-0744-C, 8S-0721-C, 8S-0717-C, 8S-0708-C, 8S-0678-C, 8S-0615-C, 8S-0559-C, 8S-0521-C, 8S-0510-C-RC, 8S-0421-C, 8S-0413-C, 8S-0405-C, 8S-0348-C-RC, 8S-0300-C, 8S-0192-C, 8S-0143-C, 8S-0144-C, 8S-0148-C, 8S-0140-C, 8S-0141-C, 8S-0093-C, 8S-0055-C, 8S-0011-C, 8S-0014-C, 8S-0016-C, 8S-0005-C, 8S-0006-C-RC.
- 510(k) numbers
- ["K021049","K022069","K024012"]
- 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