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Showing 67001–67020 of 68218 results

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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

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

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

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

Power failure having impact on software.

FDAJun 24, 2004Nationwide• ABX Diagnostics Inc

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

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

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

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

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

Toshiba American Med Sys Inc: Digital Radiography System, model DFP-8000D

Defect in the mirroring unit.

FDAJun 18, 2004Nationwide• Toshiba American Med Sys Inc

Spinal Specialties, Inc: Gertie Marx PainPak, Lot number 0504305, Reorder number 4060

Kit contains lidocaine, which has particulate matter in its ampule.

FDAJun 18, 2004MI, TX• Spinal Specialties, Inc

Advance Medical Designs Inc: Advance Medical''s, The Closed Camera System, 9'' x 96'' ...

The product may come apart when excessive force is applied to the coupler.

FDAJun 18, 2004Nationwide• Advance Medical Designs Inc

Roche Diagnostics Corp.: Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit...

May report falsely decreased patient results.

FDAJun 18, 2004Nationwide• Roche Diagnostics Corp.

Spinal Specialties, Inc: Pencil Point Spinal Tray, Lot number 0504243

Kit contains lidocaine, which has particulate matter in its ampule.

FDAJun 18, 2004MI, TX• Spinal Specialties, Inc

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