RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
Reason: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, ...
Z-1468-2020March 18, 2020Stockholm
Braemar Manufacturing, LLC
Class IITerminated
Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Reason: An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that b...
Z-1460-2020March 18, 2020Eagan, MN
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
Reason: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, ...
Z-1465-2020March 18, 2020Stockholm
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
Reason: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, ...
Z-1467-2020March 18, 2020Stockholm
Qiagen Sciences LLC
Class IITerminated
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
Reason: When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could...
Z-1476-2020March 18, 2020Germantown, MD
Braemar Manufacturing, LLC
Class IITerminated
Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Reason: An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that b...
Z-1459-2020March 18, 2020Eagan, MN
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
Reason: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, ...
Z-1466-2020March 18, 2020Stockholm
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
Reason: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, ...
Z-1463-2020March 18, 2020Stockholm
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
Reason: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, ...
Z-1464-2020March 18, 2020Stockholm
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
Reason: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, ...
Reason: A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the ...
Z-1420-2020March 11, 2020Grove City, OH
CareFusion 303, Inc.
Class IOngoing
CareFusion Alaris Syringe Module, Model 8110
Reason: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alar...
Z-1361-2020March 11, 2020San Diego, CA
Advanced Bionics, LLC
Class IIITerminated
SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by heal...
Reason: The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation fa...
Z-1441-2020March 11, 2020Valencia, CA
CareFusion 303, Inc.
Class IOngoing
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Reason: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alar...
Z-1359-2020March 11, 2020San Diego, CA
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is intended for the qualitative and quantitative anal...
Reason: A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Z-1436-2020March 11, 2020Tarrytown, NY
CareFusion 303, Inc.
Class IOngoing
CareFusion Alaris Pump Module, Model 8100
Reason: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alar...
Z-1360-2020March 11, 2020San Diego, CA
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various...
Reason: A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Z-1435-2020March 11, 2020Tarrytown, NY
CareFusion 303, Inc.
Class IOngoing
CareFusion Alaris PCA Module, Model 8120
Reason: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alar...
Z-1362-2020March 11, 2020San Diego, CA
Randox Laboratories, Limited
Class IITerminated
RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated anal...
Reason: Software version UI2550642107 for the RX Daytona + instrument released to correct the following issues: 1) The order of samples displayed is not sequential according to SID (sample...
Z-1349-2020March 4, 2020Crumlin, N/A
St Jude Medical, Cardiac Rhythm Management Division
Reason: Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients ca...
Z-1351-2020March 4, 2020Sylmar, CA
Philips North America, LLC
Class IITerminated
Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as f...
Reason: if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display Error: 602 and f...
Z-1345-2020March 4, 2020Andover, MA
Philips Medical Systems Gmbh, DMC
Class IIOngoing
CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Reason: When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Addition...
Z-1329-2020February 26, 2020Hamburg
Philips Respironics, Inc.
Class ITerminated
Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, rec...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...
Z-0950-2020February 26, 2020Murrysville, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the who...
Reason: A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Z-1339-2020February 26, 2020Malvern, PA
Philips Respironics, Inc.
Class ITerminated
Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and ala...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...