Recall Z-2471-2021— Siemens Medical Solutions USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2021-07-12, terminated 2024-10-16. It names one FDA 510(k) clearance: K201130. Product: ACUSON Juniper Diagnostic Ultrasound System. Reason: Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable..
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-12
- Terminated
- 2024-10-16
- Firm location
- Issaquah, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
ACUSON Juniper Diagnostic Ultrasound System
Reason for recall
Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
Data sourced from openFDA. This site is unofficial and independent of the FDA.