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Recall Observatory FDA recall evidence

Device product

SOMATOM Perspective 16 (Model 10891666)

Z-2475-2018

February 01, 2018

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 79665
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2475-2018

Official wording

Reason: A potential risk of unnecessary radiation exposure due to a software issue

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue