Recalls / —
—#77305
Product
Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens Medical Solutions, Oncology Care System, Concord, CA Medical charged-particle radiation therapy system.
- FDA product code
- IYE — Accelerator, Linear, Medical
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K072485
- Affected lot / code info
- All units of Part Number: 8139789
Why it was recalled
The range of tolerance is to high for the accessory holder, therefore, Wedges and other accessories do not latch to the locking mechanism correctly.
Root cause (FDA determination)
Device Design
Action the firm took
On 12/20/08, the firm issued letters via certified mail to direct consignees, informing them of the affected product and providing instructions on the recall. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for additional information.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 4040 Nelson Ave, Concord, California 94520-1200
Distribution
- Distribution pattern
- Nationwide and Worldwide
Timeline
- Recall initiated
- 2008-12-20
- Posted by FDA
- 2009-01-30
- Terminated
- 2010-12-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #77305. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.