9 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Virotek SAFEL*E*T 1.0 mm Safety Lancets, 1.0 mm depth, stock code 5000052, packaged in single unit blister packs, 150 or 200 per box, 6 boxes per carton; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089
FDA Recall
Terminated
·Efoora, Inc. dba Virotek, L.L.C.·Product code FMK·May 5, 2005
Virotek SAFEL*E*T 2.0 mm Safety Lancets, 2.0 mm depth, stock code 5000052, packaged in single unit blister packs, 200 per box, 6 boxes per carton, stock code 5000101, packaged in single unit blue cap packaging, 100 per box, and stock code 5000115, packaged in single unit blue cap packaging, 200 per box; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089
FDA Recall
Terminated
·Efoora, Inc. dba Virotek, L.L.C.·Product code FMK·May 5, 2005
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 3, 2014
Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016
882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017
BrightView SPECT, Model Number 882480
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019
BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014