Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Reason: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
Z-1907-2023June 21, 2023Mahwah, NJ
Vyaire Medical
Class IICompleted
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Reason: Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unres...
Z-1966-2023June 21, 2023Mettawa, IL
Medtronic Navigation, Inc.
Class IOngoing
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
Reason: During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize w...
Z-1630-2023June 14, 2023Lafayette, CO
BioReference Health, LLC
Class IIOngoing
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human ...
Reason: SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
Z-1676-2023June 14, 2023Elmwood Park, NJ
Medtronic Navigation, Inc.
Class IOngoing
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
Reason: In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor rese...
Z-1666-2023June 14, 2023Lafayette, CO
Philips North America Llc
Class IIOngoing
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Reason: EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a cha...
Z-1644-2023June 7, 2023Cambridge, MA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM1...
Reason: Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
Z-1647-2023June 7, 2023Best, N/A
Philips North America Llc
Class IIOngoing
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
Reason: EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a cha...
Z-1645-2023June 7, 2023Cambridge, MA
CareFusion 303, Inc.
Class IIOngoing
BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis ...
Reason: Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transact...
Z-1579-2023May 17, 2023San Diego, CA
Technidata S.A.
Class IIOngoing
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.
Reason: In a specific use case, when printing labels for slides, some labels may display wrong information
Z-1573-2023May 17, 2023Montbonnot St Martin, N/A
Inpeco S.A.
Class IIOngoing
Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
Reason: Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decre...
Z-1563-2023May 10, 2023Lugano
Inpeco S.A.
Class IIOngoing
PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
Reason: Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decre...
Z-1561-2023May 10, 2023Lugano
Inpeco S.A.
Class IIOngoing
Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
Reason: Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decre...
Z-1562-2023May 10, 2023Lugano
Spacelabs Healthcare, Inc.
Class IIOngoing
Ultraview SL (UVSL) Command Module, Model 91496
Reason: Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) N...
Z-1503-2023May 10, 2023Snoqualmie, WA
Inpeco S.A.
Class IIOngoing
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-2...
Reason: Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decre...
Z-1559-2023May 10, 2023Lugano
Inpeco S.A.
Class IIOngoing
Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-2...
Reason: Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decre...
Z-1560-2023May 10, 2023Lugano
Draeger Medical Systems, Inc.
Class IIOngoing
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Reason: The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition...
Z-1471-2023May 3, 2023Andover, MA
Draeger Medical Systems, Inc.
Class IIOngoing
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity pat...
Reason: The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition...
Z-1472-2023May 3, 2023Andover, MA
Hamilton Medical AG
Class IIOngoing
HAMILTON-C6, REF: 160021
Reason: Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the fol...
Z-1429-2023May 3, 2023Bonaduz, N/A
Radiometer Medical ApS
Class IIOngoing
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data ...
Reason: Due to potential software issue that may result in patient mix-up information.
Z-1394-2023April 26, 2023Bronshoj, N/A
Becton Dickinson & Co.
Class IIOngoing
BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing...
Reason: Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after processing has occu...
Z-1415-2023April 26, 2023Sparks, MD
Outset Medical, Inc.
Class IIOngoing
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dia...
Reason: An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
Z-1351-2023April 19, 2023San Jose, CA
Shanghai United Imaging Healthcare Co., Ltd.
Class IIOngoing
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
Reason: Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction an...
Z-1353-2023April 19, 2023Shanghai, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12...
Reason: It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the ...
Z-1281-2023March 29, 2023Stockholm, N/A
Withings
Class IIOngoing
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
Reason: A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician.
Z-1280-2023March 29, 2023Issy les Moulineaux CEDEX, N/A