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Showing 21361–21380 of 22584 results

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Aaron Medical Industries, Inc.: Battery-operated Cautery Low Temperature, fine/elongated...

The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.

FDAJun 29, 2004IN• Aaron Medical Industries, Inc.

Aaron Medical Industries, Inc.: Battery-operated Cautery High Temperature, fine/Loop/ Va...

The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.

FDAJun 29, 2004IN• Aaron Medical Industries, Inc.

Minxray Inc: MinXray P200R24 Stationary Podiatry X-Ray System, Model P...

The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.

FDAJun 29, 2004AR, CA, FL +6 more• Minxray Inc

PerkinElmer LAS Inc: RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyt...

Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed.

FDAJun 29, 2004AZ, AR, CA +24 more• PerkinElmer LAS Inc

Smiths Medical ASD, Inc.: Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Sm...

Sterility of product is not assured

FDAJun 29, 2004Nationwide• Smiths Medical ASD, Inc.

Integra LifeSciences Corporation: MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile...

Skull pins, which fractured below device specifications during QC testing, were distributed.

FDAJun 29, 2004CO, MD, NY +1 more• Integra LifeSciences Corporation

Minxray Inc: MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200...

The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.

FDAJun 29, 2004AR, CA, FL +6 more• Minxray Inc

Hill-Rom, Inc.: Hill-Rom brand TotalCare Bed System; Model P1900.

An incorrect warning label was placed on these beds. Warning should say, "do not use for life sustaining equipment....."

FDAJun 28, 2004Nationwide• Hill-Rom, Inc.

Conmed Corporation: ConMed Stealth coated Laparoscopic Electrodes with 4mm Pi...

Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below. There is potential for electrical shock.

FDAJun 28, 2004Nationwide• Conmed Corporation

Boston Scientific Corp: Boston Scientific brand Nephroureteral Stent System. Con...

Mislabeled as to size; 10FR are labeled as 8FR.

FDAJun 25, 2004MO• Boston Scientific Corp

Boston Scientific Corp: EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #9258000...

Product labeled to contain Emcee Obturators contained Emcee Dilators.

FDAJun 24, 2004IN, NJ• Boston Scientific Corp

Varian Medical Systems Inc: medical device and software systems

a malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine and a non-varian field is loaded in the treatment session.

FDAJun 24, 2004Nationwide• Varian Medical Systems Inc

ABX Diagnostics Inc: PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

Power failure having impact on software.

FDAJun 24, 2004Nationwide• ABX Diagnostics Inc

North Coast Medi-Tek Inc: E-Z-EM brand, Basic biopsy tray, catalog no. 4125.

Product contains the incorrect lot number.

FDAJun 23, 2004NY• North Coast Medi-Tek Inc

Osmetech Inc: Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 ...

In some cases patient samples with high glucose concentrations, above the reportable range of the OPTI-CCA Analyzer, may be erroneously reported as 'Low'.

FDAJun 22, 2004Nationwide• Osmetech Inc

Argon Medical Devices, Inc: Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex f...

Inadequate closure compromising sterility.

FDAJun 22, 2004CA, IN, MO +7 more• Argon Medical Devices, Inc

Smith & Nephew Inc: Tibial Base Plates

The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.

FDAJun 21, 2004Nationwide• Smith & Nephew Inc

Adac Labs: Emission Computed Tomography System

Software problems may cause the detector head to drift unexpectedly

FDAJun 21, 2004Nationwide• Adac Labs

Smith & Nephew Inc: Genesis Uni Articular Inserts

The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.

FDAJun 21, 2004Nationwide• Smith & Nephew Inc

Alsius Corporation: Alsius CoolGuard 3000 Temperature Regulation System, Mode...

Higher than expected rate of pump alarms occur under specific conditions.

FDAJun 21, 2004AL, FL, MA +4 more• Alsius Corporation

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