The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-con...
Reason: Lasers/Catheters did not calibrate during set-up prior to use.
Z-2218-2019August 14, 2019Carlsbad, CA
Abbott Gmbh & Co. KG
Class IITerminated
The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL...
Reason: All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-).
Reason: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Z-2176-2019August 14, 2019Rochester, NY
Philips Ultrasound Inc
Class IITerminated
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usa...
Reason: There is a potential that the image of one patient could get unexpectedly moved into another patient's folder when the user is using the Edit functionality on the Patient Data Entr...
Reason: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Z-2174-2019August 14, 2019Rochester, NY
Opternative Inc
Class IIOngoing
The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This ...
Reason: Lack of 510K clearance
Z-2223-2019August 14, 2019Chicago, IL
Ortho Clinical Diagnostics
Class IITerminated
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Reason: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Reason: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Z-2175-2019August 14, 2019Rochester, NY
Philips Medical Systems Nederlands
Class IITerminated
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Reason: Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine ru...
Z-1997-2019August 7, 2019Best, N/A
Elekta Inc
Class IIOngoing
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Reason: When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units a...
Z-2091-2019August 7, 2019Maryland Heights, MO
Medical Intelligence Medizintechnik Gmbh
Class IITerminated
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tra...
Reason: Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan.
Reason: Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement proc...
Z-2080-2019July 31, 2019Tempe, AZ
Elekta, Inc.
Class IITerminated
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant an...
Reason: The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during ...
Z-1980-2019July 24, 2019Atlanta, GA
Beckman Coulter Inc.
Class IITerminated
Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluz...
Reason: Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay o...
Z-1982-2019July 24, 2019Brea, CA
Hamilton Medical AG
Class ITerminated
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and ...
Reason: New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened...
Z-1874-2019July 17, 2019Bonaduz
Canon Medical System, USA, INC.
Class IITerminated
Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, wh...
Reason: software malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor stating image transmissi...
Z-1958-2019July 17, 2019Tustin, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional ima...
Reason: The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Z-1919-2019July 10, 2019Malvern, PA
Bio-Rad Laboratories, Inc
Class IIOngoing
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Reason: User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneo...
Z-1906-2019July 10, 2019Redmond, WA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images ...
Reason: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.