Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
FDA device recall Z-1652-2014 · posted 2014-05-23 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with Siemens LINAC models.
- Action taken
- Siemen sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Elekta representative.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 9
- Distribution
- US Nationwide Distribution in the states of AL, ME, PA, IL, and CA.
- Date initiated
- 2014-04-01
- Date posted
- 2014-05-23
- Date terminated
- 2015-03-16
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE MV SA (K072485) | Siemens Medical Solutions USA, Inc. | 2007-12-27 |