Company: CareFusion 303, Inc. Date of Enforcement Report: 12/11/2024 Class II PRODUCT BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 Recall Number: Z-0671-2025 REASON: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2)...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 12/11/2024 Class II PRODUCT BD Pyxis MedStation ES, REF: 323 Recall Number: Z-0670-2025 REASON: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 12/11/2024 Class: II PRODUCT BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 REASON: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a...Read More

Company: Fresenius Kabi USA Date of Enforcement Report: 12/05/2024 PRODUCT The Ivenix LVP is a large volume infusion pump designed to deliver fluids and medications from one of two inlet source containers to the patient through a single outlet. When loaded with an administration set, the LVP delivers infusion therapy to an individual patient. UDI...Read More

Company: Abbott Medical Date of Enforcement Report: 11/26/2024 Class: III PRODUCT Merlin@home Transmitter REF EX1100 The Merlin@home” (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net” Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device...Read More

Company: Zyno Medical LLC Date of Enforcement Report: 11/22/2024 Class: III PRODUCT Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional. Recall...Read More

WARNING LETTER Randox Laboratories Limited was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 696569 30 Randalstown Road Antrim BT41 4FL United Kingdom Dates: August 5, 2024 through August 8, 2024 Inspection Issue(s): The report states that “the RX series test systems, including the RX daytona,...Read More

WARNING LETTER Becton, Dickinson, and Company/CareFusion was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 691601 Becton, Dickinson, and Company/CareFusion 303, Inc. 1 Becton Drive Franklin Lakes, NJ 07417United States Dates: May 6, 2024 through May 22, 2024 Inspection Issue(s): Report states, “your firm manufactures Pyxis Medication...Read More

Company: Philips Medical Systems Technologies Ltd. Date of Enforcement Report: 11/20/2024 Class: II PRODUCT Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites. Recall Number: Z-0497-2025...Read More

Company: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Date of Enforcement Report: 11/07/2024 Class II PRODUCT SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography. Recall Number: Z-0316-2025 REASON: X-ray R/F system software with certain versions of the control board may...Read More

Company: Philips North America Llc. Date of Enforcement Report: 10/4/2024 Class II PRODUCT IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there...Read More

WARNING LETTER Rolence Ent. Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 695010 Rolence Ent. Inc. No. 18-3, Lane 231 Pu Chung Road Taoyuan District, Taoyuan City 32083 Taiwan Dates: July 8, 2024, through July 11, 2024 Inspection Issue(s): Report states, “This inspection revealed that...Read More

Company: Boston Scientific Corporation Date of Enforcement Report: 10/16/2024 Class II PRODUCT Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral...Read More

Company: Agfa Healthcare NV Date of Enforcement Report: 10/10/2024 Class II PRODUCT Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report: 10/10/2024 Class II PRODUCT StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Recall Number: Z-0050-2025 REASON: Due to two...Read More

Company: Zyno Medical LLC Date of Enforcement Report: 10/9/2024 Class II PRODUCT Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z Recall Number: Z-0005-2025 REASON: There is a defect in the air-in-line software algorithm. RECALLING FIRM/MANUFACTURER: Zyno...Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report: 10/07/2024 Class II PRODUCT Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. Recall Number: Z-0025-2025 REASON: When the DxI 9000 Access Immunoassay Analyzer with...Read More

Company: Becton, Dickinson and Company, BD Bio Sciences Date of Enforcement Report: 10/03/2024 Class II PRODUCT BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. Recall Number: Z-0009-2025 REASON: Sample preparation...Read More

Company: Becton, Dickinson and Company, BD Bio Sciences Date of Enforcement Report: 10/3/2024 Class II PRODUCT BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. Recall Number: Z-0009-2025 REASON: Sample preparation...Read More

Company: Fisher & Paykel Healthcare, Ltd. Date of Enforcement Report: 9/25/2024 Class II PRODUCT PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute...Read More

Company: Fisher & Paykel Healthcare, Ltd. Date of Enforcement Report: 9/25/2024 Class II PRODUCT PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute...Read More

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 :...Read More

Company: Datascope Corp. Date of Enforcement Report: 9/20/2024 Class I PRODUCT CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Recall Number: Z-3135-2024 REASON: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of...Read More

Company: Datascope Corp. Date of Enforcement Report: 9/20/2024 Class I PRODUCT CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Recall Number: Z-3134-2024 REASON: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of...Read More

Company: Mazor Robotics Ltd Date of Enforcement Report: 9/16/2024 Class II PRODUCT Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument Recall Number: Z-3156-2024 REASON: Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw...Read More

Company: Philips Respironics, Inc. Date of Enforcement Report: 9/4/2024 Class I PRODUCT Trilogy Evo EV300 — Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA...Read More

Company: Medtronic Inc. Date of Enforcement Report: 9/13/2024 Class II PRODUCT 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description:...Read More

WARNING LETTER Micro-X Ltd. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 692084 Micro-X Ltd.. 6 MAB Eastern Promenade, Unit 14Tonsley SA 5042Australia Dates:  May 20, 2024, through May 23, 2024 Inspection Issue(s): The report states, “This inspection revealed that these devices are adulterated within the...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 8/30/2024 Class: II PRODUCT BD Pyxis QFill Replenishment Station, REF: 138904-01 Recall Number: Z-2947-2024 REASON: Due to software issue, their is a potential when a restock label is printed for a medication stored in a non-CUBIE location, the incorrect bin for the medication is printed on the...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 8/30/2024 Class II PRODUCT BD Pyxis QFill Replenishment Station, REF: 138904-01 Recall Number: Z-2947-2024 REASON: Due to software issue, their is a potential when a restock label is printed for a medication stored in a non-CUBIE location, the incorrect bin for the medication is printed on the...Read More

WARNING LETTER Globus Medical, Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 685606 Globus Medical, Inc. Valley Forge Business Center2560 General Armistead Avenue Audubon, PA 19403 Dates: February 15, 2024, through March 7, 2024 Inspection Issue(s): These violations include, but are not limited to, the...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/16/2024 Class II PRODUCT Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump. Recall Number: Z-2581-2024 REASON: The Spectrum WBM may fail to auto-document...Read More

Company: Biointellisense Inc. Date of Enforcement Report: 8/14/2024 Class II PRODUCT BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. Recall Number: Z-2616-2024 REASON: Software anomaly causing the skin temperature...Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report: 8/9/2024 Class II PRODUCT Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. Recall Number: Z-2544-2024 REASON: The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the...Read More

Company: Philips North America Llc Date of Enforcement Report: 8/5/2024 Class II PRODUCT IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. Recall...Read More

Company: Smiths Medical ASD Inc. Date of Enforcement Report: 8/2/2024 Class: I PRODUCT CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent...Read More

Company: Beckman Coulter Mishima K.K. Date of Enforcement Report: 7/31/2024 Class II PRODUCT DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Recall Number:...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 7/17/2024 Class II PRODUCT BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES,...Read More

WARNING LETTER Criticare Technologies, Inc was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 686915 Criticare Technologies, Inc. 6901 TPC Drive, Suite 300Orlando, FL 32822United States July 12, 2024 Inspection Dates: March 21, 2024, through May 10, 2024 Inspection Issue(s): These violations include, but are not limited...Read More

Company: Philips Respironics, Inc. Date of Enforcement Report: 5/23/2024 Class I PRODUCT OmniLab Advanced+ (OLA+) Ventilator Recall Number: Z-1817-2024 REASON: Philips Respironics, Inc. is updating use instructions for OmniLab Advanced+ (OLA+) Ventilator due to a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss. Philips will correct the affected OLA+ to...Read More

Company: Echonous Inc. Date of Enforcement Report: 7/10/2024 Class II PRODUCT Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system. Recall Number: Z-2325-2024 REASON: Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd...Read More

Company: Echonous Inc. Date of Enforcement Report: 7/10/2024 Class II PRODUCT Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system. Recall Number: Z-2325-2024 REASON: Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 7/3/2024 Class II PRODUCT BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units Recall Number: Z-2262-2024 REASON: Due to a software issue there is the potential that the PC unit may not connect to the server which could impact wireless data transmission to and...Read More

Company: Siemens Healthcare Diagnostics Inc Date of Enforcement Report: 6/26/2024 Class II PRODUCT Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 Recall Number: Z-2214-2024 REASON: Siemens Healthineers has...Read More

Company: Blue Belt Technologies, Inc Date of Enforcement Report: 6/11/2024 Class II PRODUCT CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT – UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence...Read More

Company: Abbott Medical Group Date of Enforcement Report: 6/7/2024 Class I PRODUCT Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device Recall Number: Z-1921-2024 REASON: System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in...Read More

Company: Nihon Kohden America Inc Date of Enforcement Report: 6/6/2024 Class II PRODUCT BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility Recall Number: Z-2025-2024 REASON: Due to software issue...Read More

WARNING LETTER Techlem Medical Corporation was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 671395 Techlem Medical Corporation Mississauga ON December 26, 2023 Inspection Dates: June 19, 2023, through June 22, 2023 Inspection Issue(s): These violations include, but are not limited to, the following: 1. Failure...Read More

WARNING LETTER Trexo Robotics Holdings, Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 673150 Cue Health, Inc. San Diego, CA February 7, 2024 Inspection Dates: on June 3 through June 5, 2023 Inspection Issue(s): “the Trexo devices are adulterated under section 501(f)(1)(B) of...Read More

Company: Verathon, Inc. Date of Enforcement Report: 6/4/2024 Class II PRODUCT Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor Recall Number: Z-2021-2024 REASON: Due to software issues, there is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices. RECALLING...Read More