c.cam Gamma Camera, Model 9VIR1200; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hof
FDA device recall Z-0906-2007 · posted 2007-06-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Chair Breakage: Under extreme load, the chair back of the c.cam emission computed tomography system may bend and eventually break. This could be caused by the accumulated stress from heavy patients seating or stretching themselves in the chair or simply from long time use.
- Action taken
- Important Safety Notice letters dated 4/30/07 on Siemens letterhead were sent to the end users, informing them of the potential risk that the c.cam chair may bend or break under heavy load. They were told that a Siemens service representative will contact them within the next few days to arrange the repair of the chair at no cost to the end user. To ensure the chair does not become damaged, SIemens recommended that the c.cam not be used for patient scanning until the update has been performed on the chair. Any questions regarding the Important Safety Notice were directed to their service representative or Siemens' office at: 1-800-888-7436 (USA).
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 413 cameras
- Distribution
- Worldwide-USA, Canada, France, Germany, Israel, The Netherlands and Portugal.
- Date initiated
- 2007-04-30
- Date posted
- 2007-06-06
- Date terminated
- 2009-01-09
- Location
- Hoffman Estates, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| C.CAM (K031825) | Danish Diagnostic Development A/S | 2003-06-20 |