Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 44 of 120
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation o...
Reason: Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canis...
Z-1402-2022 July 27, 2022 Portage, MI
Siemens Medical Solutions USA, Inc
Class II Ongoing
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Rad...
Reason: Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivit...
Z-1426-2022 July 27, 2022 Malvern, PA
Breas Medical, Inc.
Class II Ongoing
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled p...
Reason: A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT f...
Z-1382-2022 July 20, 2022 North Billerica, MA
Siemens Medical Solutions USA, Inc
Class II Ongoing
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Num...
Reason: After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be m...
Z-1339-2022 July 13, 2022 Malvern, PA
Baxter Healthcare Corporation
Class II Ongoing
NaviCare Nurse Call/Voalte Nurse Call
Reason: An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software version...
Z-1306-2022 July 6, 2022 Deerfield, IL
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
Class II Terminated
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Reason: Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower uri...
Z-1292-2022 July 6, 2022 Seoul
Haemonetics Corporation
Class II Terminated
Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), Plate...
Reason: When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP...
Z-1298-2022 July 6, 2022 Boston, MA
Smiths Medical ASD Inc.
Class I Ongoing
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500S...
Reason: Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. I...
Z-1272-2022 June 29, 2022 Minneapolis, MN
CardioTek BV
Class II Completed
CardioTek EP-TRACER Software V2.x.
Reason: Device did not pass electrical safety testing for adequate insulation.
Z-1283-2022 June 29, 2022 Maastricht-Airport
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome...
Reason: Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Z-1268-2022 June 22, 2022 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; ...
Reason: Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Z-1267-2022 June 22, 2022 Mounds View, MN
Siemens Medical Solutions USA, Inc
Class II Ongoing
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 1076...
Reason: Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment canno...
Z-1243-2022 June 15, 2022 Malvern, PA
Medtronic Xomed, Inc.
Class II Ongoing
NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Reason: Software anomaly was identified.
Z-1223-2022 June 8, 2022 Jacksonville, FL
Dynex Technologies, Inc.
Class II Ongoing
DYNEX Agility, Agility Analyzer, Model No. 67000
Reason: Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's ...
Z-1222-2022 June 8, 2022 Chantilly, VA
Medtronic Xomed, Inc.
Class II Ongoing
NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Reason: Software anomaly was identified.
Z-1224-2022 June 8, 2022 Jacksonville, FL
Bio-Rad Laboratories, Inc.
Class II Ongoing
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Reason: The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3...
Z-1208-2022 June 8, 2022 Hercules, CA
Daavlin Distributing Company
Class II Ongoing
4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.
Reason: Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
Z-1074-2022 May 18, 2022 Bryan, OH
bioMerieux, Inc.
Class II Ongoing
VITEK 2 Systems and VITEK 2 with MYLA.
Reason: Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This c...
Z-1059-2022 May 18, 2022 Durham, NC
Philips North America Llc
Class II Terminated
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic ...
Reason: When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to N...
Z-1041-2022 May 18, 2022 Cambridge, MA
Daavlin Distributing Company
Class II Ongoing
1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 12...
Reason: Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
Z-1073-2022 May 18, 2022 Bryan, OH
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class II Ongoing
Azurion systems with software release R1.x
Reason: In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is select...
Z-0886-2022 May 11, 2022 Best, N/A
DePuy Orthopaedics, Inc.
Class II Terminated
VELYS Robotic-Assisted Solution Base Product No.: 451570100
Reason: System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and pot...
Z-1029-2022 May 11, 2022 Warsaw, IN
Becton Dickinson & Co.
Class II Terminated
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Reason: When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.
Z-1018-2022 May 11, 2022 Sparks, MD
Baxter Healthcare Corporation
Class II Ongoing
PrisMax System, Product Code 955724
Reason: This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limi...
Z-0992-2022 May 4, 2022 Deerfield, IL
Draegar Medical Systems, Inc.
Class II Ongoing
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Reason: Software issue resulting in temporary loss of central monitoring functionality.
Z-1012-2022 May 4, 2022 Andover, MA