FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Perspective 16 (Model 10891666)
- Recall number
- Z-2475-2018
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Perspective 16 (Model 10891666)
- Status
- Terminated
- Initiated
- 2018-02-01
- Posted
- 2018-03-30
- Terminated
- 2020-05-01
- Reason
- A potential risk of unnecessary radiation exposure due to a software issue
- Root cause
- Software design
- Action
- Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- Serial No. 87559 87579 87532 87539 87563 87565 87560 87555 87556 87553 87554 87526 87567 87561 87589 87569 87535 87525 87548 87541 87558 87533 87537 87522 87542 87534 87549 87546 87584 87574 87552 87600 87577 87571 87528 87540 87594 87544
- 510(k) numbers
- ["K113287"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28