Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or...
Reason: The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed b...
Z-0515-2021December 9, 2020Mansfield, MA
Biomeme, Inc.
Class IITerminated
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test co...
Reason: The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expe...
Z-0513-2021December 9, 2020Philadelphia, PA
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for...
Reason: If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to ...
Z-0478-2021December 2, 2020Stockholm, N/A
LivaNova USA Inc
Class IITerminated
VNS Therapy¿ AspireSR¿ Generator
Reason: Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software ...
Z-0462-2021November 25, 2020Houston, TX
Mako Surgical Corporation
Class IICompleted
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the dist...
Reason: Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the roboti...
Z-0472-2021November 25, 2020Davie, FL
Roche Diagnostics Operations, Inc.
Class IITerminated
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software ...
Reason: Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
Z-0461-2021November 25, 2020Indianapolis, IN
Fresenius Medical Care Holdings, Inc.
Class IICompleted
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Reason: The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid...
Z-0439-2021November 18, 2020Waltham, MA
Siemens Medical Solutions USA, Inc
Class IITerminated
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and intervent...
Reason: There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition ha...
Z-0400-2021November 11, 2020Malvern, PA
Boston Scientific Corporation
Class IITerminated
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Reason: There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.
Z-0319-2021November 11, 2020Saint Paul, MN
Pentax of America Inc
Class IITerminated
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Reason: There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does ...
Z-0292-2021November 4, 2020Montvale, NJ
Pentax of America Inc
Class IITerminated
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Reason: There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does ...
Z-0293-2021November 4, 2020Montvale, NJ
Merge Healthcare, Inc.
Class IITerminated
Merge LIS
Reason: A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
Z-0289-2021November 4, 2020Hartland, WI
Fujifilm Medical Systems U.S.A., Inc.
Class IITerminated
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM S...
Reason: FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density...
Z-0282-2021October 28, 2020Lexington, MA
Baxter Healthcare Corporation
Class ITerminated
Spectrum IQ Infusion System with Dose IQ Safety Software
Reason: Baxter is updating the device IFU for safety communication regarding cleaning practices.
Z-0123-2021October 28, 2020Deerfield, IL
Brainlab AG
Class IITerminated
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system t...
Reason: Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Z-0056-2021October 14, 2020Munich, N/A
Devicor Medical Products Inc
Class IIITerminated
Neoprobe GDS Control Unit, Model Number NPCU3
Reason: It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China...
Z-0070-2021October 14, 2020Cincinnati, OH
CHANGE HEALTHCARE CANADA COMPANY
Class IITerminated
Change Healthcare Radiology Solutions 14.0
Reason: Software defect which may potentially result in one or more images missing in a study
Z-0072-2021October 14, 2020Richmond, N/A
Siemens Medical Solutions USA, Inc
Class IITerminated
Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Defin...
Reason: Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan
Z-3025-2020October 7, 2020Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
Reason: Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset v...
Z-3005-2020September 30, 2020Malvern, PA
Life Technologies Corporation
Class IITerminated
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the ...
Reason: COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2)...
Z-2978-2020September 23, 2020Pleasanton, CA
Life Technologies Corporation
Class IITerminated
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multipl...
Reason: COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2)...
Z-2979-2020September 23, 2020Pleasanton, CA
Medtronic Inc.
Class IITerminated
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Reason: As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to th...
Z-2980-2020September 23, 2020Northridge, CA
Novarad Corporation
Class IITerminated
NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, C...
Reason: The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cros...
Z-2956-2020September 23, 2020American Fork, UT
SICAT GMBH & CO. KG
Class IITerminated
SICAT IMPLANT V2.0
Reason: A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.
Z-2951-2020September 16, 2020Bonn
RAYSEARCH LABORATORIES AB
Class IIOngoing
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
Reason: When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to th...