bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P...
Reason: Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
Z-2817-2018August 29, 2018Durham, NC
Ortho Kinematics, Inc
Class IIOngoing
Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
Reason: Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA u...
Z-2891-2018August 29, 2018West Lake Hills, TX
LIEBEL-FLARSHEIM COMPANY LLC
Class IITerminated
Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, pri...
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...
Z-2833-2018August 29, 2018Saint Louis, MO
Ortho Kinematics, Inc
Class IIOngoing
Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image fi...
Reason: Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.
Z-2890-2018August 29, 2018West Lake Hills, TX
Hitachi Medical Systems America Inc
Class IITerminated
Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images ...
Reason: The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released ...
Z-2839-2018August 29, 2018Twinsburg, OH
Biomerieux Inc
Class IITerminated
bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacte...
Reason: Missing desiccant.
Z-2874-2018August 29, 2018Hazelwood, MO
Tosoh Bioscience Inc
Class IITerminated
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the qua...
Reason: HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 4...
Z-2745-2018August 22, 2018Grove City, OH
Mako Surgical Corporation
Class IITerminated
Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the ...
Reason: Out of tolerance.
Z-2794-2018August 22, 2018Davie, FL
Spacelabs Healthcare, Ltd.
Class ITerminated
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthes...
Reason: Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
Z-2589-2018August 22, 2018Hertford
Hudson Scientific LLC
Class IITerminated
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on n...
Reason: The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding elect...
Z-2736-2018August 15, 2018Hudson, MI
Datex-Ohmeda, Inc.
Class IITerminated
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is desig...
Reason: The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
Z-2738-2018August 15, 2018Madison, WI
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Scope Power (Model 10967888)
Reason: A potential risk of unnecessary radiation exposure due to a software issue
Z-2477-2018August 8, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Emotion 6 (Model 10165888)
Reason: A potential risk of unnecessary radiation exposure due to a software issue
Z-2472-2018August 8, 2018Malvern, PA
Merge Healthcare, Inc.
Class IITerminated
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system...
Reason: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Z-2566-2018August 8, 2018Hartland, WI
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Perspective (Model 10495568)
Reason: A potential risk of unnecessary radiation exposure due to a software issue
Z-2474-2018August 8, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Emotion 16 (10165977)
Reason: A potential risk of unnecessary radiation exposure due to a software issue
Z-2473-2018August 8, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Spirit(Model 10045692 )
Reason: A potential risk of unnecessary radiation exposure due to a software issue
Z-2478-2018August 8, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Scope ( Model 10967666)
Reason: A potential risk of unnecessary radiation exposure due to a software issue
Z-2476-2018August 8, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Perspective 16 (Model 10891666)
Reason: A potential risk of unnecessary radiation exposure due to a software issue
Z-2475-2018August 8, 2018Malvern, PA
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment pl...
Reason: The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated i...
Z-2554-2018August 1, 2018Stockholm, N/A
Forte Automation Systems Inc
Class IITerminated
Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient ...
Reason: Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.
Reason: The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of two ways: A) by tr...
Reason: If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead ...
Z-2497-2018July 25, 2018Stockholm
Intel-GE Care Innovations LLC
Class IITerminated
Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for pa...
Reason: It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the back...
Z-2442-2018July 25, 2018Roseville, CA
St Jude Medical Inc.
Class IITerminated
Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the...
Reason: The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx ...