Siemens Medical Solutions USA, Inc. Recall 88405
Description: ACUSON Juniper Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc. Recall 88405 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2471-2021 |
| Event ID | 88405 |
| Event Description | ACUSON Juniper Diagnostic Ultrasound System |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 15 systems |
| Recall Reason | Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable. |
| Device Classification | 20210922 |
| Device Code Info | 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; |
| Center Classification Date | 20210914 |
| Recall Initiation Date | 20210712 |
| Recalling Firm | Siemens Medical Solutions USA, Inc. |
| Initial Notification | Letter |
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