Recall archive
59 recalls · page 1 of 3
Reported Oct 2, 2024
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 20, 2023
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system…
FDA (openFDA device enforcement)
Reported Aug 9, 2023
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Reason for recall — During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than…
FDA (openFDA device enforcement)
Reported Feb 22, 2023
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details — This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 4, 2022
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — Transducers (component of ultrasound system) may exceed recommended thermal index limits
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
FDA (openFDA device enforcement)
Reported Mar 23, 2022
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment…
FDA (openFDA device enforcement)
Reported Feb 9, 2022
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may…
FDA (openFDA device enforcement)
Reported Sep 22, 2021
ACUSON Juniper Diagnostic Ultrasound System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation.…
FDA (openFDA device enforcement)
Reported Oct 14, 2020
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
FDA (openFDA device enforcement)
Reported Sep 9, 2020
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details — This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific…
FDA (openFDA device enforcement)
Reported Sep 2, 2020
E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details — E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis…
FDA (openFDA device enforcement)
Reported Aug 28, 2019
ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details — The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 16, 2019
Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details — Improper design or specifications.
FDA (openFDA device enforcement)
Reported Nov 7, 2018
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,
FDA (openFDA device enforcement)
Reported Oct 24, 2018
Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details — The terminals on the plug may become loose and overheat.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 27, 2018
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details · Reason for recall — Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a…
FDA (openFDA device enforcement)
Reported May 30, 2018
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product details — Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform…
FDA (openFDA device enforcement)
Reported May 16, 2018
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details — The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
FDA (openFDA device enforcement)
Reported May 9, 2018
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand — Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created…
FDA (openFDA device enforcement)
Reported Mar 21, 2018
ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details — The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c…
FDA (openFDA device enforcement)
Reported Jan 31, 2018
Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product details · Reason for recall — Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
FDA (openFDA device enforcement)
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