Recall Z-1086-2015— Siemens Medical Solutions USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2012-10-23, terminated 2016-12-23. It names one FDA 510(k) clearance: K041166. Product: The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.. Reason: There is a potential for the linear bearing car to fail allowing the ball bearings to fall out..
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-23
- Terminated
- 2016-12-23
- Firm location
- Hoffman Estates, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Reason for recall
There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
Data sourced from openFDA. This site is unofficial and independent of the FDA.