Browse Device Recalls
88 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 88 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 88 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 15, 2024 | ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with... | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 15, 2024 | ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ... | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 15, 2024 | ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 1133579... | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 23, 2024 | ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Junipe... | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 23, 2024 | ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select... | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 23, 2024 | ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running softw... | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 13, 2023 | ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 | If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 12, 2023 | The following Pro.specta Emission Computed Tomography Systems that were manuf... | During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 16, 2023 | SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission | This is a potential problem with the locking mechanism that is used to secure the PET gantry in e... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 16, 2023 | SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge | This is a potential problem with the locking mechanism that is used to secure the PET gantry in e... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 16, 2023 | SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3... | This is a potential problem with the locking mechanism that is used to secure the PET gantry in e... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 11, 2022 | Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems | There is a quality issue with the three bolts that hold the CT balancing weights, which could cre... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 7, 2022 | Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only , | Transducers (component of ultrasound system) may exceed recommended thermal index limits | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 19, 2022 | Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model:... | The clip store function in the ultrasound imaging system does not work when the system has a disk... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 12, 2021 | ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B | Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 12, 2021 | ACUSON Juniper Diagnostic Ultrasound System | Due to intermittent failures of the power supply in the ultrasound system which renders it inoper... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 4, 2021 | Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz... | The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) int... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 14, 2020 | Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the de... | This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have... | Class II | Siemens Medical Solutions USA, Inc. |
| May 22, 2020 | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F | Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens M... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Si... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens ... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Sie... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 30, 2018 | Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biogr... | Improper design or specifications. | Class II | Siemens Medical Solutions USA, Inc. |
| Oct 5, 2018 | EVO Excel, Emission Computed Tomographic System, Material Number 10910501 | The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be l... | Class II | Siemens Medical Solutions USA, Inc. |
| Sep 28, 2018 | Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 105... | The terminals on the plug may become loose and overheat. | Class II | Siemens Medical Solutions USA, Inc. |
| Sep 28, 2018 | Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material... | The terminals on the plug may become loose and overheat. | Class II | Siemens Medical Solutions USA, Inc. |
| May 29, 2018 | Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 ... | Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our su... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 5, 2018 | ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medic... | The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 21, 2018 | Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provi... | Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET c... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 26, 2018 | ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imag... | The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 26, 2018 | Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray di... | Error introduced into PET images acquired and reconstructed with VJ20A software. Array values ar... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 7, 2017 | Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To det... | The Broad Quantification option of the Symbia product software version VB20A may not allow modifi... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 7, 2017 | Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To de... | The Broad Quantification option of the Symbia product software version VB20A may not allow modifi... | Class II | Siemens Medical Solutions USA, Inc. |
| Sep 18, 2017 | Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Inte... | The torque wrench used to tighten system bolts during installation was found to be out of tolerance | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 25, 2017 | Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Commu... | Siemens is releasing a letter to inform about potential data loss relevant to diagnosis. | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 30, 2017 | 18L6 HD transducer on the ACUSON S Family ultrasound systems with software ve... | When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the u... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 7, 2016 | Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6... | Firm received reports about "acquisition errors" and the deterioration of material covering the a... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 5, 2016 | e.cam and Symbia E gamma camera systems with patient beds To detect or ima... | "We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 8, 2016 | ACUSON SC2000 Ultrasound imaging system with software version VB10C and using... | While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the abi... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 31, 2016 | E.cam or Symbia systems that use foresight detectors - Product Usage: To dete... | E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may los... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 26, 2016 | The E.CAM gamma camera system Product Usage: The E.CAM gamma camera syst... | We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-000... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 26, 2016 | The Symbia gamma camera system Product Usage: The Symbia gamma camera sy... | We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-000... | Class II | Siemens Medical Solutions USA, Inc. |
| Dec 31, 2015 | The e.cam Dual Signature Gamma Camera system. Used to detect or image the di... | To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not ... | Class II | Siemens Medical Solutions USA, Inc. |
| Oct 30, 2015 | Artis systems with large display from Siemens Medical Solutions USA, Inc. In... | Due to improper soldering in a limited number of large display bypass module components of a spec... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 7, 2015 | ACUSON SC2000 ultrasound systems model 10433816 Imaging system that pro... | Siemens will provide all customers a new version of system software (VA35E or VB10C depending on ... | Class II | Siemens Medical Solutions USA, Inc. |
| Sep 5, 2015 | ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: ... | Due to a communication error between the software and V5Ms transducers rotation function, ACUSON ... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 19, 2015 | ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Mode... | The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 31, 2015 | Siemens Symbia T Series, a radiological imaging system that is a combination ... | Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbi... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 31, 2015 | Siemens Intevo Series system, a radiological imaging system that is a combina... | Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbi... | Class II | Siemens Medical Solutions USA, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.