Day

September 24, 2024
24
Sep

FDA Recall: When factory default units are changed, could lead to misdiagnosis

September 24, 2024
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 9/24/2024 Class II PRODUCT ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software. Recall Number: Z-3215-2024 REASON: If ultrasound systems with software, are changed from factory default to :...
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