CLASS II Device recall · Reported 8 Aug 2018 · FDA Enforcement Report

Somatom Emotion 16 (10165977) recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Somatom Emotion 16 (10165977), distributed nationwide in the US. The recall was initiated on 1 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2473-2018
FDA event ID: 79665
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 1 Feb 2018
FDA classified: 28 Jul 2018
Reported: 8 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

1 Feb 2018	Recall initiated by company
28 Jul 2018	Classified by FDA	+177 days
8 Aug 2018	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SOMATOM Emotion 16 (10165977)

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 79665

This product is part of a recall event; the main page for the event is Somatom Emotion 6 recalled by Siemens Medical Solutions USA.

Reported	Class	Recall	Company	Reason	Where
8 Aug 2018	CLASS II	Somatom Emotion 6 recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	Somatom Perspective 16 recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	Somatom Perspective recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	Somatom Scope Power recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	Somatom Spirit recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	Somatom Scope recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

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