Recall Z-0771-2021— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-11-24, terminated 2024-02-06. It names 6 FDA 510(k) clearances: K173607, K161196, K142955 and 3 more. Product: SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus. Reason: System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-24
- Terminated
- 2024-02-06
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
6 on FDA's record- K173607 — SOMATOM Edge Plus
- K161196 — SOMATOM Drive
- K142955 — SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
- K133589 — SOMATOM FORCE
- K121072 — SOMATOM DEFINITION FLASH
- K103127 — SOMATOM DEFINITION AS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Reason for recall
System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan
Data sourced from openFDA. This site is unofficial and independent of the FDA.