Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Reason: Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks...
Z-0190-2019October 24, 2018Tarrytown, NY
Baxter Healthcare Corporation
Class IITerminated
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Reason: If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false har...
Z-0107-2019October 24, 2018Medina, NY
GE Medical Systems, LLC
Class IITerminated
GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-I...
Reason: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or the...
Z-0111-2019October 24, 2018Waukesha, WI
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Reason: Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks...
Z-0191-2019October 24, 2018Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Reason: Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks...
Z-0192-2019October 24, 2018Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Reason: Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks...
Z-0194-2019October 24, 2018Tarrytown, NY
Terumo Cardiovascular Systems Corporation
Class IITerminated
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Reason: The service manual was not updated at the time of the release of software version 1.30.
Z-0176-2019October 24, 2018Ann Arbor, MI
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Reason: Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks...
Z-0193-2019October 24, 2018Tarrytown, NY
AS Software, Inc.
Class IITerminated
AS-OBGYN Information System version 7.824.x
Reason: Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use ...
Z-0118-2019October 24, 2018Englewood Cliffs, NJ
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Reason: Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks...
Z-0189-2019October 24, 2018Tarrytown, NY
Radiometer America Inc
Class IITerminated
ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oxim...
Reason: The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes ...
Z-0010-2019October 10, 2018Brea, CA
Johnson & Johnson Surgical Vision Inc
Class IITerminated
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: Opti...
Reason: Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown o...
Z-0066-2019October 10, 2018Milpitas, CA
Boston Scientific Corporation
Class IITerminated
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Sc...
Reason: There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
Reason: When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software comput...
Reason: Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to ...
Z-3251-2018October 3, 2018Louisville, CO
Tosoh Bioscience Inc
Class IITerminated
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the di...
Reason: Analyzers were distributed with software which lacks a 510K
Z-3244-2018October 3, 2018Grove City, OH
bioMerieux, Inc.
Class IITerminated
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 2 is an automated sys...
Reason: Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level ...
Z-3180-2018September 26, 2018Durham, NC
Mobius Imaging, LLC
Class IITerminated
AIRO Mobile CT System Model # MobiCT-32
Reason: The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after...
Z-2991-2018September 26, 2018Shirley, MA
Invivo Corporation
Class IITerminated
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Reason: Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inac...
Z-3192-2018September 26, 2018Orlando, FL
Tecan US, Inc.
Class IITerminated
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Reason: There is a software issue that can potentially impact sample identification and traceability under specific conditions when using EVOware Add On Software: Sample Tracking -Multi In...
Z-3187-2018September 26, 2018Morrisville, NC
bioMerieux, Inc.
Class IITerminated
VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated sys...
Reason: Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level ...
Reason: The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study...
Z-2992-2018September 12, 2018Greenville, SC
LIEBEL-FLARSHEIM COMPANY LLC
Class IITerminated
Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primar...
Reason: Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes...
Reason: This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.
Z-2889-2018August 29, 2018West Lake Hills, TX
Ortho Kinematics, Inc
Class IIOngoing
Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
Reason: Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. ...