FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc.
- Recall number
- Z-0042-2007
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc.
- Status
- Terminated
- Initiated
- 2006-09-30
- Posted
- 2006-10-14
- Terminated
- 2012-04-16
- Reason
- X-ray system may lose or mix images and/or lose patient data.
- Root cause
- Other
- Action
- Consignees will be notified by letter beginning 10/21/2006.
- Quantity
- 822 units
- Distribution
- Nationwide, including VA facilities in FL, NC, WA and military accounts in GA and WA. Foreign distribution to Australia, Belgium, Canada, Finland, France, Germany, Italy, Netherlands, New Zealand, Singapore, Spain, Sweden, Switzerland, UK.
- Lot, serial or model codes
- Serial numbers: E2-0001 thru E2-0065, E2-0066-CH, E2-0067 thru E2-0152, E2-0156 thru E2-0159, E2-0166, E2-7001-MH thru E2-7033-MH, E2-7034-CMH, E2-7035-MH thru E2-7056-MH, E9-0001, E9-0003, E9-0005 thru E9-0013, E9-0015 thru E9-0031, E9-0033, E9-0034, E9-0038, E9-0039, E9-0043 thru E9-0082, E9-00084, E9-0086, E9-0087, E9-0096, E9-0097, E9-0104, E9-0105, E9-0106, E9-0107, ES-0001, ES-0004, ES-0005, ES-0006, ES-0007-C, ES-0008, ES-0009, ES-0010, ES-0011-H, ES-0012-H, ES-0017, ES-0019, ES-0022-CH, ES-0029-CH, ES-0030, ES-0036-CH, ES-0037, ES-0038, ES-0039, ES-0045-H, ES-0046-CH, ES-0047, ES-0048, ES-0049-H, ES-0050 thru ES-0059, ES-0060-H, ES-0061, ES-0062-H, ES-0063-H, ES-0064, ES-0065, ES-0066-CH, ES-0067 thru ES-0080, ES-0091-H, ES-0092-CH, ES-0093, ES-0094, ES-0095, ES-0096, ES-0099-CH, ES-0100-CH, ES-0101-CH, ES-0102-CH, ES-0103, ES-0106, ES-0107, ES-7001-CMH, ES-7002-MH, ES-7003-MH, ES-7004-CMH, ES-7005-MH, ES-7006-CMH thru ES-7013-CMH, ES-7014-MH thru ES-7018-MH, ES-7019-CMH, ES-7020-CMH, ES-7022-CMH, ES-7023-CMH, ES-7024-CMH, ES-7025-CMH, ES-7026-MH, ES-7027-MH.
- 510(k) numbers
- ["K041931"]
- 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