SOMATOM Perspective 16 (Model 10891666)
FDA device recall Z-2475-2018 · posted 2018-03-30 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- A potential risk of unnecessary radiation exposure due to a software issue
- Action taken
- Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Distribution
- Nationwide
- Date initiated
- 2018-02-01
- Date posted
- 2018-03-30
- Date terminated
- 2020-05-01
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM PERSPECTIVE (K113287) | Siemens Medical Solutions USA, Inc. | 2012-05-23 |