Z-2471-2021 Class II Terminated
FDA device recall Z-2471-2021 was initiated by Siemens Medical Solutions USA, Inc. on July 12, 2021 and is designated Class II. Reason for recall: Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable. The recall status is terminated (terminated October 16, 2024). Affected quantity: 15 systems.
Recall Details
- Product Type
- Devices
- Report Date
- September 22, 2021
- Initiation Date
- July 12, 2021
- Termination Date
- October 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 systems
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.
Distribution Pattern
Worldwide distribution - U.S. Nationwide distribution in the Puerto Rico and the countries of Bosnia Herzegovina, Canada, Colombia, Germany, Greece, Italy, North Macedonia, Poland, and Slovenia.
Code Information
Model Number: 11335791 UDI: (01)04056869152059 (21)123456 (240)11335791 (422)410 Firmware version 3.8 for rev. 7 U.S. Serial Number: 555606; O.U.S. Serial Numbers: 550975; 552770; 553629; 553951; 555060; 555601; 555602; 555604; 555605; 555610; 555611; 555612; 555613; 555626; O.U.S. Inactive Serial Numbers: 555603; 555607;