FDA Medical Device Recalls (openFDA)
Source Production & Equipment Inc: M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source.
- Recall number
- Z-1717-2009
- Recalling firm
- Source Production & Equipment Inc
- Product
- M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source.
- Status
- Terminated
- Initiated
- 2008-03-03
- Posted
- not on file
- Terminated
- 2009-08-19
- Reason
- Radioactive source broke during use.
- Root cause
- Other
- Action
- Source Production and Equipment, Inc. notified the Distributor by phone and letter March 2008 and requested the return of all affected units.
- Quantity
- 3 units
- Distribution
- Nationwide Distribution -- GA, NV and NY.
- Lot, serial or model codes
- OSI A011, OSI A010, and OSI A015.
- 510(k) numbers
- ["K052947"]
- PMA numbers
- not on file
- Product code
- KXK
- Firm FEI
- 1000437833
- Firm city
- St Rose
- Firm state
- LA
- 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