e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
FDA device recall Z-0116-2015 · posted 2014-10-22 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Reports of loose bolts in the detector support structure of Symbia and e.cam systems.
- Action taken
- Undated "Customer Safety Advisory Notice" letters were sent to all direct accounts (customers). The letters stated the problem, and included instructions for customers. Customers: 1) can continue to use the devices while waiting for an inspection to be scheduled and performed; and, 2) their local service engineer will inspect the detector pivot connections and make any necessary repairs on site. Customers with any questions can contact their local service representative or Siemens Molecular Imaging at 800-888-7436.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 4,862 devices
- Distribution
- Worldwide Distribution -- USA, including the states of 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, NV, NY, OH, OK, O
- Date initiated
- 2013-10-28
- Date posted
- 2014-10-22
- Date terminated
- 2016-12-23
- Location
- Hoffman Estates, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IP500 NUCLEAR GAMMA CAMERA SYSTEM (K952109) | Siemens Medical Solutions USA, Inc. | 1995-08-23 |