Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in
FDA device recall Z-2043-2014 · posted 2014-07-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose.
- Action taken
- A Customer Safety Advisory Notice dated April 23, 2014 was sent to every direct account. The letter included instructions for direct accounts to discontinue use of the collimator cart and notify the local service representative if they notice or suspect tha one or more casters are loose (which would be indicated by shaking while the cart is in motion). Otherwise, a service representative will be contacting the direct account within the following 3 months to schedule a retention bracket installation. Direct accounts with questions can contact Siemens Medical Solutions USA, Inc. at 800-888-7436.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 531 systems
- Distribution
- Worldwide Distribution- US: Nationwide (AK ; AL ; AR ; AZ ; CA ; CO ; CT ; DE ; FL ; GA ; HI ; IA ; ID ; IL ; IN ; KS ; KY ; LA ; MA ; MD ; ME ; MI ; MN ; MO ; MS ; MT ; NC ; ND ; NE ; NH ; NJ ; NM ;
- Date initiated
- 2014-04-23
- Date posted
- 2014-07-11
- Date terminated
- 2016-12-23
- Location
- Hoffman Estates, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYMBIA (K131634) | Siemens Medical Solutions USA, Inc. | 2013-08-16 |