Device product
ACUSON Juniper Diagnostic Ultrasound System
Z-2471-2021
Product summary
- Event
- Event 88405
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 systems
- Official record key
device-enforcement:Z-2471-2021
Official wording
Reason: Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
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;
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.
Derived failure modes
-
Unknown
Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.