Z-2471-2021 Class II Terminated
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;