Somatom Emotion 6 CT Systems

510(k) K023687

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK023687	Date22 Nov 2002Cleared	StatusActive

6 recalls · FDA

2 recalls, same reason
- Terminated Z-2472-2018 FDA Class II initiated 1 Feb 2018
- Terminated Z-2473-2018 FDA Class II initiated 1 Feb 2018
A potential risk of unnecessary radiation exposure due to a software issue
- Terminated Z-1300-2016 FDA Class II initiated 15 Feb 2016
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio Pro" and "Cardio Retro".
- Terminated Z-1721-2014 FDA Class II initiated 21 Mar 2014
The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.
- Terminated Z-2452-2008 FDA Unclassified (pre-2012) initiated 5 Aug 2008
Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse which is designed to open in the event of a short circuit condition between the internal switch contacts.
- Terminated Z-0157-05 FDA Unclassified (pre-2012) initiated 28 Sep 2004
Calcium Scoring feature on this devices is not closing properly after patient's exams.

1 jurisdiction

United States — FDA 510(k) Active

510(k)