Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-se
FDA device recall Z-1721-2014 · posted 2014-06-04 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.
- Action taken
- Siemens sent a Customer Safety Advisory Notice/ Field Safety Notice letter dated March 21, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that the system modification would be implemented by Siemens service specialists in April 2014 to correct the problem.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 345
- Distribution
- US Nationwide Distribution in the states of IA, TX, FL, NE, NY, OH, NC, KS, IL, CA, OK including PR.
- Date initiated
- 2014-03-21
- Date posted
- 2014-06-04
- Date terminated
- 2015-03-16
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM EMOTION 16 (K050297) | Siemens Medical Solution, Inc. USA | 2005-03-01 |
| SOMATOM SPIRIT (K042328) | Siemens Medical Systems, Inc. | 2004-09-14 |
| SOMATOM EMOTION 6 CT SYSTEMS (K023687) | Siemens Medical Systems, Inc. | 2002-11-22 |