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Z-2475-2018 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-2475-2018 was initiated by Siemens Medical Solutions USA, Inc on Feb 1, 2018 and is designated Class II. Reason for recall: A potential risk of unnecessary radiation exposure due to a software issue The recall status is terminated (terminated May 1, 2020).

Recall Details

Product Type: Devices
Report Date: Aug 8, 2018
Initiation Date: Feb 1, 2018
Termination Date: May 1, 2020
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

SOMATOM Perspective 16 (Model 10891666)

Reason for Recall

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

Distribution Pattern

Nationwide

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2475-2018
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.