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Showing 20421–20440 of 22584 results

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Siemens Medical Solutions USA, Inc: Mammomat Novation Digital Mammography System. Model numbe...

potential issue (image acquisition may become interrupted) when using multiple network nodes

FDAMay 25, 2005Nationwide• Siemens Medical Solutions USA, Inc

Becton Dickinson & Company: #309661 -- Syringe only ll 20 mL

The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.

FDAMay 25, 2005Nationwide• Becton Dickinson & Company

Toshiba American Med Sys Inc: Magnetic Resonance Imaging Systems; Visart, Excelart / E...

Patient information A is displayed with images for patient B.

FDAMay 25, 2005Nationwide• Toshiba American Med Sys Inc

Becton Dickinson & Company: # 309603 -- Syringe 5Ml LL syringe.

The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.

FDAMay 25, 2005Nationwide• Becton Dickinson & Company

Becton Dickinson & Company: BD Syringes - #309585 -- Piston Syringe, Syringe 3ML LL...

The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.

FDAMay 25, 2005Nationwide• Becton Dickinson & Company

Becton Dickinson & Company: #309604 -- 10 mL syringe

The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.

FDAMay 25, 2005Nationwide• Becton Dickinson & Company

Becton Dickinson & Company: # 309604 -- Syringe 10 mL LL

The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.

FDAMay 25, 2005Nationwide• Becton Dickinson & Company

Becton Dickinson & Company: #309644 -- 10 ml syringe with 20 G1'' Needle

The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.

FDAMay 25, 2005Nationwide• Becton Dickinson & Company

B. Braun Medical, Inc.: Right Heart Catheter Product Line: Catalog Number 601129...

Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.

FDAMay 25, 2005Nationwide• B. Braun Medical, Inc.

Radiometer America Inc: Package Insert which accompanies the Hematocrit and Metab...

The package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The range stated on the package insert was too low to generate accurate Hct test results (The control ranges were acceptable for the glucose and lactate testing).

FDAMay 24, 2005Nationwide• Radiometer America Inc

Elekta, Inc.: Leksell SurgiPlan

Images from a different patient can be imported without a warning for the user.

FDAMay 23, 2005Nationwide• Elekta, Inc.

Toshiba American Med Sys Inc: Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A...

If the measurement mode is started from the Doppler mode and then the sweep speed setting is changed by the assigned user function, the measurement of the time direction results don't correspond to the actual values.

FDAMay 23, 2005Nationwide• Toshiba American Med Sys Inc

Synovis Surgical Inovation Div. of: Peri-Strips Dry with Veritas Collagen Matrix Staple Line ...

Device is contained in 2 pouches. The outer pouch's seal may be compromised; this may render the exterior of the interior pouch non-sterile.

FDAMay 23, 2005AL, AK, AZ +10 more• Synovis Surgical Inovation Div. of

Beckman Coulter Inc: Potassium Electrode Tip; Part No.s: 668281 Tip Assembly- ...

Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.

FDAMay 20, 2005Nationwide• Beckman Coulter Inc

Provalis Diagnostics: Product is in2it A1C In-Office Analyzer Test Cartridge. ...

Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartridges.

FDAMay 20, 2005AZ, FL, GA +5 more• Provalis Diagnostics

Maquet Inc: Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary ...

Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheter's FDA approval status.

FDAMay 20, 2005Nationwide• Maquet Inc

Hill-Rom Manufacturing, Inc.: Clinitron At Home Air Fluidized Therapy Bed

Sudden unexpected lowering of the head of the bed may occur due to failure of the had of the bed actuator.

FDAMay 20, 2005AL, FL, KY +7 more• Hill-Rom Manufacturing, Inc.

Hill-Rom, Inc.: Hill-Rom Century+ Bed, Model P1400.

Sleep bed pivot bolts may break, allowing the head section to shift or to drop to one side.

FDAMay 20, 2005Nationwide• Hill-Rom, Inc.

Instrumentation Laboratory Co.: ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers...

Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy

FDAMay 19, 2005Nationwide• Instrumentation Laboratory Co.

Esa Biosciences, Inc.: LeadCare Blood Lead Testing System Kits Catalog Number: 7...

Lead test results may be reported lower than the actual value

FDAMay 19, 2005Nationwide• Esa Biosciences, Inc.

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