Medical Device Recalls

CFRES ID Product Res No Recall Status Product Code Event Date Initiated Recalling Firm Product Description
94207 Z-2470-2010 Terminated HXX 2010-08-26 Wright Medical Technology Inc DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY, NON-STERILE, EC REP Wright Medical EMEA, Krijgsman 11, 1186 DM Amstelveen, The Netherlands, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
74762 Z-2471-2010 Terminated IZI 2008-10-23 Philips Medical Systems North America Co. Phillips Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet). Intended use for Angiographic X-ray system with and without a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
93308 Z-2488-2010 Terminated DYB 2010-07-29 Arrow International Inc MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters
93219 Z-2353-2010 Terminated GKZ 2010-04-16 Abbott Laboratories CELL-DYN Sapphire, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.
93230 Z-2344-2010 Terminated NQP 2009-02-09 Synthes USA (HQ), Inc. TI N-Hance Rod 150mm Sterile The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
84099 Z-2339-2010 Terminated JAK 2009-02-03 Toshiba American Medical Systems Inc Toshiba Aquilion ONE CT SystemTSX-301 A/2D
88820 Z-2371-2010 Terminated GXZ 2010-02-01 Stryker Instruments Div. of Stryker Corporation 17G x 150mm Tuohy Stimulation Catheter Kit, REF 553-218-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
88805 Z-2356-2010 Terminated FRN 2010-02-01 Stryker Instruments Div. of Stryker Corporation Stryker Pain Pump 2 Luer Cap, REF 525-401, Rx, Sterile, Product of Ireland Manufactured for Stryker Instruments Kalamazoo MI
92243 Z-2420-2010 Terminated HWE 2010-06-02 Stryker Instruments Div. of Stryker Corporation Stryker Bur Guard REF 2296-301, Stryker Instruments, Kalamazoo, MI (USA) The Impaction Bur Guard is intended to be used with the Impaction Drill. The drill is used for surgical procedures involving precision drilling and cutting of bone and hard tissue. The bur guard covers the nose of the handpiece and the shaft of the cutting accessory to prevent exposure to heat and moving parts, as well as minimize bur whip and handpiece vibration.
69555 Z-2422-2010 Terminated KPR 2007-12-13 Philips Medical Systems North America Co. Phillips DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2. The device is manufactured by Philips Medical Systems DMC GmbH, RontgenstraBe 24, 22335 Hamburg, Germany.
73607 Z-2434-2010 Terminated LNH 2008-09-19 Philips Medical Systems North America Co. Phillips Panorama 0.6T MRI Nuclear Magnetic Resonance Imaging System, Philips Panorama 0.6T Open MRI system, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143
94240 Z-0057-2011 Terminated LXH 2010-08-23 Stryker Howmedica Osteonics Corp. Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts.
92349 Z-0037-2011 Terminated LDS 2010-06-07 Cenorin HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). This device does not have the external heater unit known as High Throughput Heater. Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 540***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***". Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended for use at healthcare provided clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.
89091 Z-2387-2010 Terminated JIX 2010-02-26 Siemens Healthcare Diagnostics, Inc. Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, Salicylate, and Triglycerides methods on the Dimension Vista system.
93265 Z-2403-2010 Terminated FMW 2007-08-29 Invacare Corporation Mattress Model 5185 and 5185XL. Manufactured by: Invacare Corp., 2101 East Lake Mary Blvd., Sanford, FL 32773. Mattress Model 5185 and 5185XL were packaged in the IVC Bed Models BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED12-1633, BED38LOW-1633, VCPKGIVC-1633 OR VCPKGIVC2-1633.
92928 Z-2333-2010 Terminated BTM 2010-06-22 Westmed Inc BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathing patient with a face mask or through an artificial airway. A manual emergency ventilator is a device, incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.
91332 Z-2400-2010 Terminated MMI 2010-04-13 Siemens Healthcare Diagnostics, Inc. Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)
67011 Z-2406-2010 Terminated IXR 2008-01-04 Philips Medical Systems North America Co. Phillips Easy Diagnost DSI is a Easy Diagnost Digital Spot Imaging system. It has a capability to create digital images from an analog system. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.
88965 Z-2435-2010 Terminated MNR 2009-12-03 Ventus Medical, Inc. The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and physiologic recorders.
96673 Z-1032-2011 Terminated GEH 2010-12-20 Galil Medical, Inc. SeedNet MRI Cryosurgical System, model FPRCH2035, and the following system is not approved in the US: CryoHit MRI Cryoblation System, model FPRCH2048. The system is a software controlled cryoblation system designed to destroy targeted tissue using a minimally invasive percutaneous approach. Freezing and thawing of the tissue is achieved through the use of the Joule-Thompson effect, using a high-pressure gas distributed through closed-end needles placed into the patient;s target organ. The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. The modified SeedNet is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The modified SeedNet has the following specific indications: - Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia BPH); - Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention); - Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin); - Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia); - General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.); - ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth); - Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions); - Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids). The Modified SeedNet System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.
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