RecallRadar

FDA Device recall Z-2478-2018

SOMATOM Spirit(Model 10045692 )

On 2018-08-08 the FDA classified a Class II recall of SOMATOM Spirit(Model 10045692 ) by Siemens Medical Solutions Usa, citing A potential risk of unnecessary radiation exposure due to a software issue.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2478-2018
ClassificationClass II
Statusterminated
Initiated2018-02-01
Published2018-08-08
Last updated2026-09-13 11:54 UTC
CompanySiemens Medical Solutions Usa
DistributionUS

Product

SOMATOM Spirit(Model 10045692 )

Reason

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

Identifiers

code_infoSerial No. 31621 31245 79670 31092 31313 31611

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2478-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.