Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
Reason: Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).
Z-1492-2014April 30, 2014Louvain La Neuve, N/A
Boston Scientific Corporation
Class IITerminated
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
Reason: Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distan...
Z-1487-2014April 30, 2014Fremont, CA
Siemens Medical Solutions USA, Inc.
Class IITerminated
Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.
Reason: When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could rep...
Z-1504-2014April 30, 2014Mountain View, CA
RAYSEARCH LABORATORIES AB
Class IITerminated
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Reason: RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-ima...
Z-1481-2014April 30, 2014Stockholm, N/A
Philips Medical Systems, Inc.
Class IITerminated
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital med...
Reason: Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations
Z-1495-2014April 30, 2014Andover, MA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Reason: A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.
Z-1464-2014April 23, 2014Cleveland, OH
Del Mar Reynolds Medical, Ltd.
Class ITerminated
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Reason: The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
Z-1442-2014April 23, 2014Hertford, N/A
Brainlab AG
Class IITerminated
Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
Reason: The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatom...
Z-1469-2014April 23, 2014Feldkirchen, N/A
Philips Medical Systems, Inc.
Class IITerminated
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
Reason: Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.
Z-1438-2014April 16, 2014Andover, MA
RAYSEARCH LABORATORIES AB
Class IITerminated
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Reason: RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Z-1308-2014April 9, 2014Stockholm, N/A
Philips Medical Systems (Cleveland), Inc.
Class IITerminated
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
Reason: Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) Sys...
Z-1312-2014April 9, 2014Fitchburg, WI
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
Reason: Potential for dose errors due to software program errors.
Z-1307-2014April 9, 2014Stockholm, N/A
Elekta, Inc.
Class IITerminated
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radia...
Reason: The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.
Z-1322-2014April 9, 2014Atlanta, GA
ZOLL Medical Corporation
Class IITerminated
Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
Reason: Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used
Z-1311-2014April 9, 2014Chelmsford, MA
Bio-Rad Laboratories, Inc.
Class IITerminated
D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single...
Reason: On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.
Z-1299-2014April 2, 2014Hercules, CA
Spacelabs Healthcare, Llc
Class IITerminated
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computer...
Reason: Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from inst...
Z-1273-2014April 2, 2014Snoqualmie, WA
Velocity Medical Solutions, LLC
Class IITerminated
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison...
Reason: An anomaly was detected such that, under certain conditions, a summed dose created by Velocity replaces the calculated dose from an approved plan in Eclipse when importing the dose...
Z-1275-2014April 2, 2014Atlanta, GA
GE Healthcare, LLC
Class IITerminated
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cros...
Reason: GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT s...
Z-1245-2014March 26, 2014Waukesha, WI
GE Healthcare, LLC
Class IITerminated
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas an...
Reason: GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invas...
Z-1175-2014March 19, 2014Waukesha, WI
Clarity Medical Systems Inc
Class IITerminated
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
Reason: Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
Z-1154-2014March 19, 2014Pleasanton, CA
GE Healthcare, LLC
Class IITerminated
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version...
Reason: GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle...
Z-1163-2014March 19, 2014Waukesha, WI
Horiba Instruments, Inc dba Horiba Medical
Class IITerminated
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software dat...
Reason: HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the L...
Z-1173-2014March 19, 2014Irvine, CA
Veridex, LLC
Class IITerminated
CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTR...
Reason: Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.
Z-1195-2014March 19, 2014Raritan, NJ
Elekta, Inc.
Class IITerminated
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Reason: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Z-1085-2014March 12, 2014Atlanta, GA
Elekta, Inc.
Class IITerminated
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
Reason: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.