Core noun
Device recall evidence
Joined enrichment rows that support device recall linkage and root-cause wording.
Indexed record set
39,516 evidence rows
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- Evidence
- device-recall:cfres:142598
- Product
- Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
- Join
- Official recall number ·
Z-0689-2016 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:142562
- Product
- GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
- Join
- Official recall number ·
Z-0681-2016 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:142560
- Product
- GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
- Join
- Official recall number ·
Z-0680-2016 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:142594
- Product
- UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
- Join
- Official recall number ·
Z-0622-2016 - Root cause
- Process change control
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- Evidence
- device-recall:cfres:142058
- Product
- Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature. The catheter shafts are comprised of a PTFE inner liner, a reinforcing layer of stainless steel braid, and an outer polymer jacket. The distal end has a radiopaque polymer tip, while the proximal end has a hub with flush luer fitting to allow flush, contrast injection and aspiration polymer .
- Join
- Official recall number ·
Z-0588-2016 - Root cause
- Process control
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- Evidence
- device-recall:cfres:142399
- Product
- Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
- Join
- Official recall number ·
Z-0596-2016 - Root cause
- Software design
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- Evidence
- device-recall:cfres:142202
- Product
- MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
- Join
- Official recall number ·
Z-0562-2016 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:142241
- Product
- MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
- Join
- Official recall number ·
Z-0557-2016 - Root cause
- Software design
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- Evidence
- device-recall:cfres:142017
- Product
- Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.
- Join
- Official recall number ·
Z-0566-2016 - Root cause
- Mixed-up of materials/components
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- Evidence
- device-recall:cfres:141901
- Product
- Merge Cardio with software version 10.1 LA.
- Join
- Official recall number ·
Z-0555-2016 - Root cause
- Process control
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- Evidence
- device-recall:cfres:141655
- Product
- Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
- Join
- Official recall number ·
Z-0704-2016 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:142411
- Product
- INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
- Join
- Official recall number ·
Z-0723-2016 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:142414
- Product
- INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
- Join
- Official recall number ·
Z-0725-2016 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:142889
- Product
- MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
- Join
- Official recall number ·
Z-0735-2016 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:141660
- Product
- UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures
- Join
- Official recall number ·
Z-0708-2016 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:141654
- Product
- Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
- Join
- Official recall number ·
Z-0703-2016 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:142406
- Product
- INTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
- Join
- Official recall number ·
Z-0718-2016 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:142485
- Product
- MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use.
- Join
- Official recall number ·
Z-0733-2016 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:143569
- Product
- CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
- Join
- Official recall number ·
Z-0771-2016 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:143015
- Product
- SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.
- Join
- Official recall number ·
Z-0787-2016 - Root cause
- Component design/selection
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- Evidence
- device-recall:cfres:142730
- Product
- IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Join
- Official recall number ·
Z-0775-2016 - Root cause
- Labeling Change Control
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- Evidence
- device-recall:cfres:142619
- Product
- RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560, 5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30.0, 8.30.1, 8.30.3, 8.30.3.1, 8.30.4, 8.30.5, 8.30.6, 8.30.6.1, 8.30.6.2, 8.30.6.3, 8.30.7, 8.30.7.1, 8.30.7.2, 8.30.7.3, 8.30.7.3-Hopkins, 8.30.7.4, 8.30.7.5, 8.30.7.5.b, 8.30.7.6, 8.30.7.7, 8.30.7.8.
- Join
- Official recall number ·
Z-0794-2016 - Root cause
- Software design
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- Evidence
- device-recall:cfres:141936
- Product
- ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU
- Join
- Official recall number ·
Z-0525-2016 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:142156
- Product
- Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
- Join
- Official recall number ·
Z-0439-2016 - Root cause
- Process change control
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- Evidence
- device-recall:cfres:141491
- Product
- NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
- Join
- Official recall number ·
Z-0327-2016 - Root cause
- Software Design Change