FDA Medical Device Recalls (openFDA)
Intraop Medical Corporation: Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.
- Recall number
- Z-0014-2009
- Recalling firm
- Intraop Medical Corporation
- Product
- Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.
- Status
- Terminated
- Initiated
- 2008-06-20
- Posted
- 2008-10-03
- Terminated
- 2011-04-05
- Reason
- Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.
- Root cause
- Component design/selection
- Action
- Recall initiated on 06/20/2008, advising users via Advisory Notice that a safety upgrade would be available. Two options are given to either self inspect the product or schedule an Intraop Authorized Field Service Engineer to visit their facility to perform the inspection. The letter notes that if no nut failure was evident, the machine could still be used. The firm continues to send retrofit kits.
- Quantity
- 24 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- all units
- 510(k) numbers
- ["K981112"]
- PMA numbers
- not on file
- Product code
- LHN
- Firm FEI
- 3001874253
- Firm city
- Sunnyvale
- Firm state
- CA
- 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