FDA Medical Device Recalls (openFDA)
Deerfield Imaging: IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
- Recall number
- Z-3211-2017
- Recalling firm
- Deerfield Imaging
- Product
- IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
- Status
- Terminated
- Initiated
- 2017-08-14
- Posted
- not on file
- Terminated
- 2018-05-29
- Reason
- incorrect thread on thumbscrews
- Root cause
- Process control
- Action
- The firm notified the consignees by email on 08/14/2017. The letter stated that the screws would be replaced.
- Quantity
- 6 screws
- Distribution
- IL, OR, PA
- Lot, serial or model codes
- Serial Numbers: 10006657, 10006658, 10006725, 10006660, 10006726, 10006659
- 510(k) numbers
- K103493
- PMA numbers
- not on file
- Product code
- HBL
- Firm FEI
- 3010326005
- Firm city
- Minnetonka
- Firm state
- MN
- 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