Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and plane...
Reason: Software defect causing intermittently slow response of Host.
Z-2372-2016August 17, 2016Cleveland, OH
Merge Healthcare, Inc.
Class IITerminated
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitall...
Reason: Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
Z-2301-2016August 10, 2016Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of ...
Reason: A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
Z-2303-2016August 10, 2016Hartland, WI
Medtronic Navigation, Inc.
Class IITerminated
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an ai...
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based ...
Z-2315-2016August 10, 2016Louisville, CO
Medtronic Navigation, Inc.
Class IITerminated
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an a...
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based ...
Z-2313-2016August 10, 2016Louisville, CO
Medtronic Navigation, Inc.
Class IITerminated
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for pr...
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based ...
Z-2314-2016August 10, 2016Louisville, CO
Medtronic Navigation, Inc.
Class IITerminated
Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for...
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based ...
Z-2316-2016August 10, 2016Louisville, CO
Merge Healthcare, Inc.
Class IITerminated
Merge HEMO software.
Reason: The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
Z-2341-2016August 10, 2016Hartland, WI
Olympus Scientific Solutions Americas
Class IIOngoing
Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-...
Reason: Trigger lock option does not always prevent x-ray generation. Specifically if the unit is in test mode or repeat test mode then the trigger lock may not prevent x-ray initiation w...
Z-2255-2016August 10, 2016Waltham, MA
Medtronic Navigation, Inc.
Class IITerminated
MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended a...
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based ...
Z-2319-2016August 10, 2016Louisville, CO
Medtronic Navigation, Inc.
Class IITerminated
MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an a...
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based ...
Z-2318-2016August 10, 2016Louisville, CO
Medtronic Navigation, Inc.
Class IITerminated
Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as ...
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based ...
Z-2317-2016August 10, 2016Louisville, CO
B-K Medical A/S
Class IITerminated
BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of th...
Reason: In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation facto...
Z-2325-2016August 10, 2016Herlev
Ge Healthcare It
Class IITerminated
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to...
Reason: A software defect was discovered that causes images to be out of context with clinical information.
Z-2300-2016August 3, 2016Barrington, IL
Draeger Medical, Inc.
Class IITerminated
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/80...
Reason: Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
Z-2295-2016August 3, 2016Telford, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.
Reason: Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.
Z-2245-2016July 27, 2016Malvern, PA
WalkMed Infusion, LLC
Class IITerminated
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Soft...
Reason: Eight (8) issues were identified which may affect the results generated by the system software version.
Z-2256-2016July 27, 2016Tarrytown, NY
WalkMed Infusion, LLC
Class IITerminated
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Soft...
Z-2219-2016July 27, 2016Englewood, CO
Toshiba American Medical Systems Inc
Class IITerminated
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Reason: During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value w...
Z-2188-2016July 27, 2016Tustin, CA
Carestream Health Inc
Class IITerminated
Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the ...
Reason: A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of...
Z-2217-2016July 27, 2016Rochester, NY
Hospira Inc.
Class IITerminated
LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or ho...
Reason: Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (t...
Z-2141-2016July 20, 2016Lake Forest, IL
Merge Healthcare, Inc.
Class IITerminated
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and quali...
Reason: Potential data loss occurs as a result of the software archiving not working properly.
Z-2144-2016July 20, 2016Hartland, WI
Ortho-Clinical Diagnostics
Class IIITerminated
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
Reason: If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the int...
Z-2143-2016July 20, 2016Rochester, NY
Hospira Inc.
Class IITerminated
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the d...
Reason: Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (t...