c.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed); Siemens Medical Solutions USA, Inc., Mole
FDA device recall Z-0304-2008 · posted 2007-12-19 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Unintended Motion: A hardware fault in the c.cam system can cause the system to experience unintended motion, thereby causing a collision hazard.
- Action taken
- Urgent Field Correction Recall letters dated 9/11/07, on Siemens letter head were sent to the end users via U.S. certified mail, informing them of the potential risk of unintended motion of the detector head resulting in a collision hazard. The end users were warned not to press any of the detection motion buttons while simultaneously holding the collision over ride button on the c.cam hand controller, and were provided steps to take if the system stops during an acquisition and displays the Collision Error message. They were told that a Siemens service representative will contact them within 90 days to schedule the repair of the c.cam at no cost to the end user. Any questions regarding the Important Safety Notice were directed to their service representative or Siemens office at: 1-800-888-7436 (USA).
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 486 units
- Distribution
- Worldwide: USA including Puerto Rico and Brazil, Canada, France, Germany, Great Britain, Israel, The Netherlands, and Portugal.
- Date initiated
- 2007-09-17
- Date posted
- 2007-12-19
- 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 |