Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 41 of 120
Brainlab AG
Class II Ongoing
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Reason: Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Z-1259-2023 March 22, 2023 Munich, N/A
Boston Scientific Corporation
Class II Ongoing
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Reason: Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For th...
Z-1216-2023 March 15, 2023 Saint Paul, MN
Sensus Healthcare, Inc.
Class II Terminated
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
Reason: When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient.
Z-1235-2023 March 15, 2023 Boca Raton, FL
Stryker Corporation
Class II Ongoing
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.
Reason: Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result...
Z-1184-2023 March 8, 2023 Portage, MI
CareFusion 303, Inc.
Class II Ongoing
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Reason: Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to tra...
Z-1192-2023 March 8, 2023 San Diego, CA
Stryker Corporation
Class II Ongoing
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.
Reason: Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result...
Z-1185-2023 March 8, 2023 Portage, MI
Stryker Corporation
Class II Ongoing
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Reason: Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result...
Z-1186-2023 March 8, 2023 Portage, MI
Siemens Medical Solutions USA, Inc
Class II Ongoing
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
Reason: Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set ...
Z-1166-2023 March 1, 2023 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Ongoing
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
Reason: Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set ...
Z-1164-2023 March 1, 2023 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Ongoing
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
Reason: Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set ...
Z-1165-2023 March 1, 2023 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Ongoing
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
Reason: Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set ...
Z-1167-2023 March 1, 2023 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Ongoing
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
Reason: Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set ...
Z-1168-2023 March 1, 2023 Malvern, PA
NuVasive Inc
Class III Ongoing
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Reason: Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity p...
Z-1052-2023 February 15, 2023 San Diego, CA
Getinge Usa Sales Inc
Class I Ongoing
Getinge Flow-c Anesthesia System, Part No. 6887700
Reason: Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentra...
Z-0960-2023 February 1, 2023 Wayne, NJ
Agfa Healthcare NV
Class II Ongoing
Agfa HealthCare Enterprise Imaging XERO Viewer
Reason: There is a software defect that can cause issues with images.
Z-1004-2023 February 1, 2023 Mortsel, N/A
Align Technology Inc
Class II Completed
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Reason: 3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect pa...
Z-1017-2023 February 1, 2023 San Jose, CA
Siemens Medical Solutions USA, Inc
Class II Ongoing
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 110...
Reason: In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously ...
Z-1003-2023 February 1, 2023 Malvern, PA
Getinge Usa Sales Inc
Class I Ongoing
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Reason: Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentra...
Z-0959-2023 February 1, 2023 Wayne, NJ
Getinge Usa Sales Inc
Class I Ongoing
Getinge Flow-e Anesthesia System, Part No. 6887900
Reason: Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentra...
Z-0961-2023 February 1, 2023 Wayne, NJ
Cardiac Assist, Inc
Class I Terminated
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circui...
Reason: A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the ...
Z-0926-2023 January 25, 2023 Pittsburgh, PA
Medtronic Neuromodulation
Class II Ongoing
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Reason: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Z-0913-2023 January 18, 2023 Minneapolis, MN
CareFusion 303, Inc.
Class II Ongoing
BD Pyxis MedBank System - Product Label/labeling pending
Reason: Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and li...
Z-0928-2023 January 18, 2023 San Diego, CA
Medtronic Neuromodulation
Class II Ongoing
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
Reason: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Z-0912-2023 January 18, 2023 Minneapolis, MN
Medtronic Neuromodulation
Class II Ongoing
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
Reason: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Z-0911-2023 January 18, 2023 Minneapolis, MN
Medtronic Neuromodulation
Class II Ongoing
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
Reason: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Z-0915-2023 January 18, 2023 Minneapolis, MN