The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo
FDA device recall Z-2713-2014 · posted 2014-09-29 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in t
- Action taken
- Siemens sent an Undated Customer Safety Advisory Notice letter to all direct accounts (customers). The letters included instructions for customers to: 1) continue to use the system(s) while waiting for the field correction to be scheduled and performed unless the system exhibits abnormal noise or vibration in which case the system(s) should not be used and the local Siemens Medical Solutions USA service engineer should be contacted; 2) ensure that the letter is placed in the Systems Owner's Manual and share it with support staff; and, 3) if the product was sold to another party, forward the letter to that party. A local service engineer will contact the customer to schedule the servicing of the affected systems by December 2014 which will consist of replacing the mounting plate. If customers have any questions about this issue, customer can contact their local service representative by calling 800-888-7436.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 48 systems
- Distribution
- Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WAM WI, WY, Distr
- Date initiated
- 2014-07-28
- Date posted
- 2014-09-29
- Date terminated
- 2016-12-23
- Location
- Hoffman Estates, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYMBIA (K131634) | Siemens Medical Solutions USA, Inc. | 2013-08-16 |
| SYMBIA, VERSION 4.0 (K082506) | Siemens Medical Solutions USA, Inc. | 2008-11-21 |