SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by c
FDA device recall Z-1558-2016 · posted 2016-04-22 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected). There is also a risk of a potential misdiagnosis in using this protocol for surgery planning. Investigations revealed an incorrect parameterization of the reconstruction algorithm applied for the pediatric head kernel as cause of the problem.
- Action taken
- Siemens distributed a Safety Advisory Notice dated April 1, 2016, to affected customers The letter identified the affected product, problem, how to avoid potential risks, how the issue will be resolved. and actions to be taken. Customers were asked to observe the safety notice and comply with the corresponding measures until further notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 37 CTsystems
- Distribution
- US Nationwide Distribution : NC, NH, IL, MA, WA, PA, MD, MN, TX, NY, SC, OH, CA, KY, MT, IA
- Date initiated
- 2016-04-01
- Date posted
- 2016-04-22
- Date terminated
- 2017-04-17
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM FORCE (K133589) | Siemens Medical Solutions USA, Inc. | 2014-04-17 |