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:129687
- Product
- Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
- Join
- Official recall number ·
Z-0325-2016 - Root cause
- Software Design Change
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- Evidence
- device-recall:cfres:140959
- Product
- RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions. This system is designed to travel over a specialized 0.009 guidewire to guide the path of burr travel to deliver therapy where intended. The guidewires are intended for use with the Rotablator Rotational Atherectomy System.
- Join
- Official recall number ·
Z-0211-2016 - Root cause
- Component change control
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- Evidence
- device-recall:cfres:140969
- Product
- Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients.
- Join
- Official recall number ·
Z-0270-2016 - Root cause
- No Marketing Application
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- Evidence
- device-recall:cfres:142044
- Product
- Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
- Join
- Official recall number ·
Z-0419-2016 - Root cause
- Process control
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- Evidence
- device-recall:cfres:141768
- Product
- MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
- Join
- Official recall number ·
Z-0425-2016 - Root cause
- Software design
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- Evidence
- device-recall:cfres:141769
- Product
- MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
- Join
- Official recall number ·
Z-0426-2016 - Root cause
- Software design
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- Evidence
- device-recall:cfres:141973
- Product
- Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A 1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set). Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate.
- Join
- Official recall number ·
Z-0415-2016 - Root cause
- Unknown/Undetermined by firm
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- Evidence
- device-recall:cfres:142378
- Product
- Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Tray catalog number is: Tray designated as ST0485-037.
- Join
- Official recall number ·
Z-0448-2016 - Root cause
- Component design/selection
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- Evidence
- device-recall:cfres:140714
- Product
- MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes.
- Join
- Official recall number ·
Z-0437-2016 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:141778
- Product
- LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.
- Join
- Official recall number ·
Z-0381-2016 - Root cause
- Packaging process control
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- Evidence
- device-recall:cfres:141530
- Product
- IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
- Join
- Official recall number ·
Z-0357-2016 - Root cause
- Software design
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- Evidence
- device-recall:cfres:141277
- Product
- Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.
- Join
- Official recall number ·
Z-0362-2016 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:141782
- Product
- LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
- Join
- Official recall number ·
Z-0384-2016 - Root cause
- Packaging process control
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- Evidence
- device-recall:cfres:141784
- Product
- LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
- Join
- Official recall number ·
Z-0386-2016 - Root cause
- Packaging process control
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- Evidence
- device-recall:cfres:141612
- Product
- Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
- Join
- Official recall number ·
Z-0366-2016 - Root cause
- Other
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- Evidence
- device-recall:cfres:141509
- Product
- MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
- Join
- Official recall number ·
Z-0279-2016 - Root cause
- Labeling mix-ups
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- Evidence
- device-recall:cfres:141457
- Product
- CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
- Join
- Official recall number ·
Z-0290-2016 - Root cause
- Process design
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- Evidence
- device-recall:cfres:141191
- Product
- Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
- Join
- Official recall number ·
Z-0313-2016 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:140703
- Product
- Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.
- Join
- Official recall number ·
Z-0320-2016 - Root cause
- Software design
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- Evidence
- device-recall:cfres:141185
- Product
- DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
- Join
- Official recall number ·
Z-0309-2016 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:141180
- Product
- DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
- Join
- Official recall number ·
Z-0306-2016 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:129444
- Product
- Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
- Join
- Official recall number ·
Z-0409-2016 - Root cause
- Software design
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- Evidence
- device-recall:cfres:139378
- Product
- Philips Healthcare Ingenuity CT Computed Tomography X-ray system
- Join
- Official recall number ·
Z-0408-2016 - Root cause
- Radiation Control for Health and Safety Act
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- Evidence
- device-recall:cfres:139376
- Product
- Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
- Join
- Official recall number ·
Z-0407-2016 - Root cause
- Radiation Control for Health and Safety Act
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- Evidence
- device-recall:cfres:141893
- Product
- DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D
- Join
- Official recall number ·
Z-0499-2016 - Root cause
- Nonconforming Material/Component