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Showing 62361–62380 of 68218 results

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Mentor Texas, Inc: Irrigation Tubing, 25'; Part Number 5120-25; distributed ...

During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.

FDAApr 21, 2008PR• Mentor Texas, Inc

Mentor Texas, Inc: Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed...

During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.

FDAApr 21, 2008PR• Mentor Texas, Inc

Mentor Texas, Inc: Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distribute...

During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.

FDAApr 21, 2008PR• Mentor Texas, Inc

Mentor Texas, Inc: Contour Genesis Infiltration Tubing, 13'; Part Number CG-...

During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.

FDAApr 21, 2008PR• Mentor Texas, Inc

Intuitive Surgical, Inc.: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Card...

The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.

FDAApr 18, 2008Nationwide• Intuitive Surgical, Inc.

Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (cir...

The power supply may fail to charge the batteries due to various hardware malfunctions.

FDAApr 17, 2008Nationwide• Terumo Cardiovascular Systems Corporation

Sunquest Information Systems, Inc.: Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3. ...

Sunquest has identified a problem with IGO interfaces when performing an Online File Cleanup (OFC) that can lead to the test results of one patient filing to another patient when the order codes are the same. Performing an OFC prior to all results being assigned an accession number may cause the patient results to remain in a temporary file where they can be incorrectly associated to the wrong pat

FDAApr 17, 2008Nationwide• Sunquest Information Systems, Inc.

Biomet Sports Medicine: BIOMET EZLoc 9-10mm TM Femoral Fixation, Catalog Number ...

This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-1

FDAApr 17, 2008Nationwide• Biomet Sports Medicine

Biomet Sports Medicine: BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 90...

This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-1

FDAApr 17, 2008Nationwide• Biomet Sports Medicine

Abbott Spine: PathFinder Cannulated T-Handle Bone Awl, Part Number 1155...

Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely. The firm has received internal non-conformances and complaints where the tips of the Awl were worn and damaged. Of the tip breaks, six have had material missing. During the same period, there were 15 complaints reported where the tip broke off at the weld after repeated use (1-3 years). The firm found several possible ca

FDAApr 17, 2008AZ, AR, CA +19 more• Abbott Spine

Biomet Microfixation, Inc.: Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model num...

The working tips of the Stella Osteotomes are thicker than specification.

FDAApr 16, 2008MO, NM, TX• Biomet Microfixation, Inc.

Physio Control, Inc.: Physio-Control LIFEPAK 20e defibrillator/monitor, sold i...

The LIFEPAK 20e defibrillator / monitors with software versions 058 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning prior to anal

FDAApr 16, 2008Nationwide• Physio Control, Inc.

Physio Control, Inc.: Physio-Control LIFEPAK 20 defibrillator/monitor is indic...

The LIFEPAK 20 defibrillator / monitors with software versions 048, 052 and 054 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning p

FDAApr 16, 2008Nationwide• Physio Control, Inc.

Physio Control, Inc.: Physio-Control LIFEPAK 12 defibrillator/monitor is indica...

The LIFEPAK 12 defibrillator / monitors with software version 130 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning prior to analys

FDAApr 16, 2008Nationwide• Physio Control, Inc.

OEC Medical Systems, Inc: OEC 9800 Image Intensified fluoroscopic x-ray system (inc...

Use of existing four-pedal footswitch on a different machine may cause various operational errors.

FDAApr 15, 2008Nationwide• OEC Medical Systems, Inc

Merit Medical Systems, Inc.: Custom Kit, REF: K05-00843, Revision L, Sterile, Merit M...

Convenience kits may be non-sterile due to inadequate package sealing.

FDAApr 15, 2008MO, OR• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Ste...

Convenience kits may be non-sterile due to inadequate package sealing.

FDAApr 15, 2008MO, OR• Merit Medical Systems, Inc.

OEC Medical Systems, Inc: OEC 9900 Elite Image-intensified fluoroscopic x-ray syste...

Use of existing four-pedal footswitch on a different machine may cause various operational errors.

FDAApr 15, 2008Nationwide• OEC Medical Systems, Inc

Siemens Healthcare Diagnostics, Inc.: Dimension Flex Reagent Cartridge C-Reactive Protein Exten...

falsely elevated results in EDTA plasma samples

FDAApr 15, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

Medtronic Neuromodulation: Model 8596SC Intrathecal Catheter Pump Segment Revision K...

The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period.

FDAApr 14, 2008Nationwide• Medtronic Neuromodulation

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