Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative s
FDA device recall Z-0014-2009 · posted 2008-10-03 · Terminated
Recall details
- Recalling firm
- Intraop Medical Corporation
- Reason for recall
- Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- LHN
- Quantity affected
- 24 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2008-06-20
- Date posted
- 2008-10-03
- Date terminated
- 2011-04-05
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOBETRON (K981112) | Intraop Medical, Inc. | 1998-07-24 |