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Siemens Medical Solutions USA, Inc. Recall 88405

Description: ACUSON Juniper Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc. Recall 88405 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2471-2021
Event ID88405
Event DescriptionACUSON Juniper Diagnostic Ultrasound System
Product TypeDevices
DistributionWorldwide 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.
Quantity15 systems
Recall ReasonDue to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
Device Classification20210922
Device Code InfoModel 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 Date20210914
Recall Initiation Date20210712
Recalling FirmSiemens Medical Solutions USA, Inc.
Initial Notification Letter
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