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FDA (Device enforcement)Recalled 2021-07-12closedclass ii

Siemens Medical Solutions USA, Inc.: ACUSON Juniper Diagnostic Ultrasound System

Is my product affected?

ACUSON Juniper Diagnostic Ultrasound System

  • UPC 04056869152059

Check against the official notice below — it lists the full affected range.

What happened

Siemens Medical Solutions USA, Inc. is recalling 15 ACUSON Juniper Diagnostic Ultrasound Systems due to intermittent power supply failures that can render the systems inoperable. The affected systems are Model Number 11335791 with specific serial numbers, and they were distributed worldwide including throughout the United States, Puerto Rico, and in Bosnia Herzegovina, Canada, Colombia, Germany, Greece, Italy, North Macedonia, Poland, and Slovenia.

The recall notice does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.

Details from the source

Reason for recall: Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable. 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 Lot/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;

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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