FDA Device · 2015
FDA Device recalls in 2015
RecallRadar indexes 2,495 FDA Device recall notices published in 2015. By classification: 77 Class I, 2,300 Class II, 118 Class III.
- Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment
FDA Device · Class II · 2015-06-17 · Elekta - enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Cap…
FDA Device · Class II · 2015-06-17 · Ortho Clinical Diagnostics - Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
FDA Device · Class II · 2015-06-17 · Advanced Back Technologies - EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002
FDA Device · Class II · 2015-06-17 · Advanced Sterilization Products - Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Ima…
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological la…
FDA Device · Class II · 2015-06-17 · Coopersurgical - TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Im…
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refracto…
FDA Device · Class II · 2015-06-17 · Heartware - M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total…
FDA Device · Class I · 2015-06-17 · Zimmer - Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treat…
FDA Device · Class II · 2015-06-17 · Biomet - Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging sy…
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers
FDA Device · Class II · 2015-06-17 · Abbott Laboratories - Gyrus ACMI Diego Elite Tubeset
FDA Device · Class II · 2015-06-17 · Gyrus Acmi - VITROS 4600 Chemistry System, Software Version 3.2 & Below
FDA Device · Class II · 2015-06-17 · Ortho Clinical Diagnostics - Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and d…
FDA Device · Class II · 2015-06-17 · Ortho Clinical Diagnostics - HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205
FDA Device · Class I · 2015-06-17 · Heartware - Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging s…
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - AccuChek Spirit insulin infusion pump
FDA Device · Class II · 2015-06-17 · Roche Diabetes Care - Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Im…
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
FDA Device · Class II · 2015-06-17 · Fresenius Medical Care Holdings - Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates)
FDA Device · Class II · 2015-06-17 · Remel - BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabular Sys…
FDA Device · Class II · 2015-06-17 · Smith And Nephew - Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25
FDA Device · Class II · 2015-06-17 · Vilex In Tennessee - VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in…
FDA Device · Class II · 2015-06-17 · Ortho Clinical Diagnostics - Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25
FDA Device · Class II · 2015-06-17 · Vilex In Tennessee - R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular Sys…
FDA Device · Class II · 2015-06-17 · Smith And Nephew - Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging sys…
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems…
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System
FDA Device · Class II · 2015-06-17 · Roche Diabetes Care - GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
FDA Device · Class II · 2015-06-17 · Ge Oec Medical Systems - MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging…
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular Sys…
FDA Device · Class II · 2015-06-17 · Smith And Nephew - HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205
FDA Device · Class I · 2015-06-17 · Heartware - GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging s…
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - BBL Port A Cul tubes, catalog number 221606
FDA Device · Class II · 2015-06-17 · Becton Dickinson And - Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in ge…
FDA Device · Class II · 2015-06-17 · Gyrus Acmi - FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient…
FDA Device · Class I · 2015-06-17 · Maquet Cardiovascular Us Sales - Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
FDA Device · Class II · 2015-06-17 · Advanced Back Technologies - Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular Sys…
FDA Device · Class II · 2015-06-17 · Smith And Nephew - Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging s…
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile…
FDA Device · Class II · 2015-06-17 · Orthofix - Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - AGFA DX-D 100 is a mobile digital radiography x-ray system
FDA Device · Class II · 2015-06-17 · Agfa Healthcare - MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular Sys…
FDA Device · Class II · 2015-06-17 · Smith And Nephew - GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25
FDA Device · Class II · 2015-06-17 · Vilex In Tennessee - Dimension Vista Systems LOCI Thyroid Stimulating Hormone
FDA Device · Class II · 2015-06-10 · Siemens Healthcare Diagnostics - Dade Actin Activated Cephaloplastin Reagent
FDA Device · Class II · 2015-06-10 · Siemens Healthcare Diagnostics - syngo Workflow SLR
FDA Device · Class II · 2015-06-10 · Siemens Medical Solutions Usa - Tibial Alignment Guide
FDA Device · Class II · 2015-06-10 · Zimmer Cas - PRI Femoral Impactor Block for knee prosthesis surgery
FDA Device · Class II · 2015-06-10 · Zimmer - Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A
FDA Device · Class II · 2015-06-10 · Smiths Medical Asd - VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics…
FDA Device · Class III · 2015-06-10 · Ortho Clinical Diagnostics - Syngo.via and Syngo.x
FDA Device · Class II · 2015-06-10 · Siemens Medical Solutions Usa - 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe
FDA Device · Class II · 2015-06-10 · Mrp - ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose…
FDA Device · Class II · 2015-06-10 · Coreva Health Science - Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code…
FDA Device · Class I · 2015-06-10 · Synovis Surgical Innovations - Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System
FDA Device · Class II · 2015-06-10 · Siemens Healthcare Diagnostics - Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75
FDA Device · Class II · 2015-06-10 · Edwards Lifesciences - 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication f…
FDA Device · Class II · 2015-06-10 · Synthes - Cortical Screw for M/DN Intramedullary Fixation
FDA Device · Class II · 2015-06-10 · Zimmer - Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose o…
FDA Device · Class II · 2015-06-10 · Elekta - EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest
FDA Device · Class II · 2015-06-10 · Nidek - The Alcon Custom Pak
FDA Device · Class II · 2015-06-10 · Alcon Research - Brilliance iCT Computed Tomography X-ray system
FDA Device · Class II · 2015-06-10 · Philips Medical Systems Cleveland - D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap
FDA Device · Class II · 2015-06-03 · Ge Healthcare - SIEMENS Luminos Agile Max
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Usa - SOMATOM Perspective
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Usa - Direct Water feed Kit, Catalog#10373222
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Diagnostics - Liquid Waste Bottle Kit, Catalog#10386287
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Diagnostics - Liquid Waste Bottle, Catalog#10291587
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Diagnostics - Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40
FDA Device · Class II · 2015-06-03 · Medtronic Neuromodulation - EliteCore Full Core Biopsy Device
FDA Device · Class II · 2015-06-03 · Stryker Instruments Div - Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ra…
FDA Device · Class II · 2015-06-03 · Philips Medical Systems Cleveland - Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm
FDA Device · Class II · 2015-06-03 · Mindray Ds Usa - Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an…
FDA Device · Class II · 2015-06-03 · Maquet Cardiovascular Us Sales - 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the…
FDA Device · Class II · 2015-06-03 · Terumo Cardiovascular Systems - Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vi…
FDA Device · Class II · 2015-06-03 · Alere Scarborough - Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization…
FDA Device · Class III · 2015-06-03 · Volk Optical - CODMAN 3000 Series Refill Set- Huber needles
FDA Device · Class II · 2015-06-03 · Codman And Shurtleff - SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107
FDA Device · Class II · 2015-06-03 · Biosense Webster - SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Usa - SIEMENS Uroskop Omnia Max
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Usa - RaySearch RayStation 2.5, 3.0, 3.5 and 4.0
FDA Device · Class II · 2015-06-03 · Raysearch Laboratories Ab - Elastic Knee Support
FDA Device · Class II · 2015-06-03 · United Surgical Associates
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