Diagnostic Equipment Recalls

Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.

American Medical Systems Innovation Center - Silicon Valley

Class I - Dangerous

validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

May 28, 2015 Diagnostic Equipment Nationwide View Details →

Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.

American Medical Systems Innovation Center - Silicon Valley

Class I - Dangerous

validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

May 28, 2015 Diagnostic Equipment Nationwide View Details →

Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

Volcano

Class I - Dangerous

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

Jun 22, 2015 Diagnostic Equipment Nationwide View Details →

Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.

American Medical Systems Innovation Center - Silicon Valley

Class I - Dangerous

validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

May 28, 2015 Diagnostic Equipment Nationwide View Details →

Fiber Stripper, 200¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.

American Medical Systems Innovation Center - Silicon Valley

Class I - Dangerous

validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sure flex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

May 28, 2015 Diagnostic Equipment Nationwide View Details →

GE Healthcare, Precision MPi fluoroscopic imaging systems.

GE Healthcare

Class I - Dangerous

A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.

Jun 12, 2015 Diagnostic Equipment Nationwide View Details →

GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Jul 1, 2015 Diagnostic Equipment Nationwide View Details →

GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Jul 1, 2015 Diagnostic Equipment Nationwide View Details →

ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.

Siemens Healthcare Diagnostics

Class I - Dangerous

System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems.

May 19, 2015 Diagnostic Equipment Nationwide View Details →

GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Jul 1, 2015 Diagnostic Equipment Nationwide View Details →

Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.

American Medical Systems Innovation Center - Silicon Valley

Class I - Dangerous

validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

May 28, 2015 Diagnostic Equipment Nationwide View Details →

Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

Volcano

Class I - Dangerous

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

Jun 22, 2015 Diagnostic Equipment Nationwide View Details →

Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

Volcano

Class I - Dangerous

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

Jun 22, 2015 Diagnostic Equipment Nationwide View Details →

GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Jul 1, 2015 Diagnostic Equipment Nationwide View Details →

RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

Eizo

Class I - Dangerous

EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.

Jul 7, 2015 Diagnostic Equipment Nationwide View Details →

RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

Eizo

Class I - Dangerous

EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.

Jul 7, 2015 Diagnostic Equipment Nationwide View Details →

Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Alere Scarborough, Inc.

Class I - Dangerous

Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit

Jun 26, 2015 Diagnostic Equipment Nationwide View Details →

RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners.

Eizo

Class I - Dangerous

EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.

Jul 7, 2015 Diagnostic Equipment Nationwide View Details →

IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.

AGFA Healthcare

Class I - Dangerous

Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect.

Jun 26, 2015 Diagnostic Equipment View Details →

BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.

BD Biosciences, Systems & Reagents

Class I - Dangerous

Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).

Jun 15, 2015 Diagnostic Equipment Nationwide View Details →