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Showing 67301–67320 of 68218 results

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Philips Medical Systems (Cleveland) Inc: Philips MX8000 IDT CT Scanner System, 10 & 16 slice images.

The CT couch may move downward to its lower limit without command.

FDAMar 8, 2004Nationwide• Philips Medical Systems (Cleveland) Inc

Boston Scientific Corporation: PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen ,...

Lumens may have incorrect lumen size marked on them.

FDAMar 5, 2004Nationwide• Boston Scientific Corporation

Roche Diagnostics Corp.: Tecan clinical workstation; Tecan Genesis 150 front end, ...

If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.

FDAMar 5, 2004Nationwide• Roche Diagnostics Corp.

Boston Scientific Corporation: PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK...

Lumens may have incorrect lumen size marked on them.

FDAMar 5, 2004Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains...

Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.

FDAMar 5, 2004Nationwide• Boston Scientific Corporation

Instrumentation Laboratory Co.: ACL Futura Instrument Analyzer

Software may cause instrument to omit step causing reagent carrover which may effect patient test result

FDAMar 4, 2004FL• Instrumentation Laboratory Co.

Hill-Rom Manufacturing, Inc.: Magnum II Bariatric Patient Care System

Bed may pose a health hazard due to: A) Inability to articulate the frame during transport, B) Exposed sharp edge of footplate, C) Shear point between seat section and lymph panel and D) Patient fall.

FDAMar 4, 2004Nationwide• Hill-Rom Manufacturing, Inc.

Gish Biomedical Inc: Vision Hollow Fiber Oxygenator with GBS Coating

Customers reported leakage.

FDAMar 4, 2004AR, CA, CT +10 more• Gish Biomedical Inc

Instrumentation Laboratory Co.: ACL Advance Instrument Analyzer

Software may cause instrument to omit step causing reagent carrover which may effect patient test result

FDAMar 4, 2004FL• Instrumentation Laboratory Co.

Surgical Specialties Puerto Rico, Inc. Road: Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up,...

Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.

FDAMar 3, 2004Nationwide• Surgical Specialties Puerto Rico, Inc. Road

Surgical Specialties Puerto Rico, Inc. Road: Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up...

Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.

FDAMar 3, 2004Nationwide• Surgical Specialties Puerto Rico, Inc. Road

Surgical Specialties Puerto Rico, Inc. Road: Stylus Brand Angled Knife - 54-1010, Sharptome Crescent K...

Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.

FDAMar 3, 2004Nationwide• Surgical Specialties Puerto Rico, Inc. Road

ADAC Laboratories: Philips Pinnacle3 Version 6.4a Radiation Therapy Planning...

Dose delivery in the wrong location may occur when using a Elekta Leksell headframe.

FDAMar 3, 2004Nationwide• ADAC Laboratories

ADAC Laboratories: Pinnacle3 Radiation Therapy Planning System, Version 7.0e...

A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe.

FDAMar 3, 2004Nationwide• ADAC Laboratories

ADAC Laboratories: Philips ADAC Pinnacle3 Version 6.4a Radiation Therapy Pla...

Dose delivery in the wrong location may occur when using a Elekta Leksell headframe.

FDAMar 3, 2004Nationwide• ADAC Laboratories

Surgical Specialties Puerto Rico, Inc. Road: Stylus Angled Knife - 52-2835 Clear Corneal Knife, double...

Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.

FDAMar 3, 2004Nationwide• Surgical Specialties Puerto Rico, Inc. Road

Surgical Specialties Puerto Rico, Inc. Road: Stylus Brand Angled Knives - 52-2912, Slit Knife, paralle...

Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.

FDAMar 3, 2004Nationwide• Surgical Specialties Puerto Rico, Inc. Road

Medical Device Technologies, Inc.: BioPince Full Core Biopsy Instrument packed in aTyvek/pl...

The outer plastic blister packagiing material may be cracked thereby compromising the device's sterility barrier.

FDAMar 2, 2004Nationwide• Medical Device Technologies, Inc.

Medtronic MiniMed: Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. ...

Possibility of interrupted insulin flow. This posting is for a recall that occurred in March 2004, also posted on the FDA website in 2004.

FDAMar 2, 2004Nationwide• Medtronic MiniMed

Ross Products Division Abbott Laboratories: Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit...

The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient.

FDAMar 1, 2004Nationwide• Ross Products Division Abbott Laboratories

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