SOMATOM Perspective 16 (Model 10891666) recallZ-2475-2018 · Siemens Medical Solutions USA, Inc · initiated Feb 1, 2018
Class II Terminated All recalls posted in March 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A potential risk of unnecessary radiation exposure due to a software issue
FDA root cause category: Software design
What the company is doing
Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.
Recall details
- Recall number
- Z-2475-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 1, 2018
- Posted by the FDA
- Mar 30, 2018
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product code
- JAK
- FDA submissions
- K113287
- Distribution
- Nationwide
Product description
SOMATOM Perspective 16 (Model 10891666)
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K113287 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Somatom Perspective 10495568Siemens Shanghai Medical Equipment Ltd. · System, x-ray, tomography, computed4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 79665).
- Z-2474-2018 · TerminatedSOMATOM Perspective (Model 10495568)
- Z-2476-2018 · TerminatedSOMATOM Scope ( Model 10967666)
- Z-2477-2018 · TerminatedSOMATOM Scope Power (Model 10967888)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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