Reason: To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations ...
Z-0319-2016December 2, 2015Malvern, PA
Brainlab AG
Class IITerminated
BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localizat...
Reason: Instances of data sets not being accurately registered to the patient anatomy were observed.
Z-0282-2016November 25, 2015Feldkirchen, N/A
AGFA Healthcare Corp.
Class IITerminated
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Numbe...
Reason: Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were...
Z-0283-2016November 25, 2015Greenville, SC
Hamilton Medical, Inc.
Class ITerminated
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and opti...
Reason: Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardl...
Z-0151-2016November 11, 2015Reno, NV
Otto Bock Healthcare GmbH
Class IITerminated
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
Reason: A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. When sitting, the prosthetic foot can go into the Relief Function to move the foot...
Reason: Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versions 2.2.1 through 2.8. The user modified parameters would not be saved as expected, ...
Z-0231-2016November 11, 2015Rochester, NY
Steris Corporation
Class IIITerminated
AMSCO 400 and AMSCO C Small Steam Sterilizers
Reason: In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator...
Z-0210-2016November 11, 2015Mentor, OH
Brainlab AG
Class IITerminated
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images t...
Reason: Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.
Z-0218-2016November 11, 2015Feldkirchen, N/A
Siemens Medical Solutions USA, Inc.
Class IITerminated
ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purpos...
Reason: Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be implemented to address situati...
Z-0182-2016November 4, 2015Mountain View, CA
Varian Medical Systems, Inc.
Class IITerminated
ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image mana...
Reason: An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be trans...
Z-0170-2016November 4, 2015Palo Alto, CA
Philips Medical Systems, Inc.
Class IITerminated
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic...
Reason: In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines...
Z-0135-2016October 28, 2015Andover, MA
Natus Neurology Inc
Class IITerminated
NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical pur...
Reason: When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuri...
Z-0117-2016October 21, 2015Middleton, WI
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spir...
Reason: software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Co...
Z-0019-2016October 14, 2015Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
Reason: Software and firmware bugs
Z-0107-2016October 14, 2015Malvern, PA
Toshiba American Medical Systems Inc
Class IITerminated
Celesteion PCA-9000A/2 PET/CT System
Reason: It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.
Z-0005-2016October 14, 2015Tustin, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In a...
Reason: This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running SW version 4.2 or 4.3. The safety-related issues, which were described ...
Z-0106-2016October 14, 2015Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral...
Reason: software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Co...
Z-0021-2016October 14, 2015Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spi...
Reason: software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Co...
Z-0020-2016October 14, 2015Malvern, PA
Beckman Coulter Inc.
Class IITerminated
MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility t...
Reason: The software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.
Z-2809-2015September 30, 2015Brea, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded...
Reason: A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
Z-2812-2015September 30, 2015Malvern, PA
Bayer Healthcare
Class IITerminated
Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing...
Reason: Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upr...
Z-2775-2015September 23, 2015Indianola, PA
Siemens Medical Solutions USA, Inc.
Class IITerminated
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo...
Reason: The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. ...
Z-2783-2015September 23, 2015Mountain View, CA
RAYSEARCH LABORATORIES AB
Class IITerminated
Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit se...
Reason: An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose diffe...
Z-2785-2015September 23, 2015Stockholm
Terumo Cardiovascular Systems Corporation
Class IITerminated
CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocri...
Reason: Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.