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SOMATOM Emotion 16 (10165977)

FDA Device Recall #Z-2473-2018 — Class II — February 1, 2018

Recall Summary

Recall Number Z-2473-2018
Classification Class II — Moderate risk
Date Initiated February 1, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity N/A

Product Description

SOMATOM Emotion 16 (10165977)

Reason for Recall

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

Distribution Pattern

Nationwide

Lot / Code Information

Serial No. 32515 85907 32310 80551 32254 32156 32109 32319 80857 80640 80981 85661 85575 86359 32322 80849 32567 80413 86757 32370 32448 86521 32317 32504 86522 32568 80811 32190 85980 32490 32477 80525 80584 32552 80411 32587 86060 32526 85584 32185 32563 32364 32415 85765 32187 85756 85757 85657 32514 85913 80410 32295 32473 80988 86089 32120 80461 86405 32408 32512 32118 32309 32378 80475 32478 80531 32420 80755 85794 80876 80826 32123 32139 80836 80916 32159 80586 80862 80595 85875 32537 32472 80523 80519 80874 32401 80840 86286 86844 32605 32237 32674 32198 32673 80441 85520 80405 80762 85865 85641 85562 86431 86662 80795 85929 85543 32628 86022 32594 86368 85862 32461 85861 86401 80656 32326 80516 80873 32259 86360 86425 80706 80442 86429 32503 85656 86057 32334 80605 32407 32323 32124 32117 32229 32257 32375 32406 86284 32212 85960 86007 85852 85987 85999 32371 80444 86557 32298 85596 32315 32441 85653 32363 86013 32529 32532 32268 80548 32643 80976 80832 32200 32225 32244 85692 32221 32596 32252 32357 85538 80831 86320 32417 32452 32125 86032 32180 32126 32293 32227 32349 32641 32495 32427 32216 32581 80700 80498 85687 32573 85595 86605 80902 32591 80671 80467 86243 80600 80750 86714 80466 80518 80505 80530 32412 86208 80599 80937 86632 32637 32301 80973 32339 80479 32597 80430 32624 80815 86142 86292 86128 85842 86514 80927 32141 32277 32226 32424 32425 80659 32411 32391 32292 32127 86515 80637 80629 32281 32129 32492 32273 32469 85914 85795 32551 32213 80446 86287 32470 32320 85693 32402 80672 32324 32578 32531 32610 32488 32368 80485 80871 32215 32409 32376 80797 86357 80594 80474 32435 32432 86052 86285 80683 32346 80535 32270 80677 32493 32303 32580 80591 32328 32362 80823 32395 86358 32447 32169 80696 80526 80628 32589 32442

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Z-1240-2026 Class II NAEOTOM Alpha Software applications: syngo.C... Dec 19, 2025
Z-1239-2026 Class II SOMATOM X.ceed Software applications: syngo.... Dec 19, 2025

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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