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Showing 86441–86460 of 92420 results

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Sonosite, Inc.: SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P040...

22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.

FDADec 12, 2005Nationwide• Sonosite, Inc.

Siemens Medical Solutions USA, Inc: Arcadis Varic Mobile X-ray System

patient information can be stored in another patient's file.

FDADec 12, 2005Nationwide• Siemens Medical Solutions USA, Inc

Roche Diagnostics Corp.: Roche brand Omni S6 Blood Gas Analyzer; Catalog # 0333715...

Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2.

FDADec 9, 2005CA, FL, GA +10 more• Roche Diagnostics Corp.

Medtronic Gastroenterology Urology: Medtronic Slimline Single-Use Internal Reference pH Cathe...

Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the Digitrapper pH recorder. Medtronic has determined that patient safety is not compromised, but catheter function may be affected and damage may result to the Digitrapper pH recorder.

FDADec 9, 2005CA, CO, FL +3 more• Medtronic Gastroenterology Urology

Roche Diagnostics Corp.: Roche brand Omni S4 Blood Gas Analyzer; Catalog # 0333713...

Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2.

FDADec 9, 2005CA, FL, GA +10 more• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand Omni S2 Blood Gas Analyzer; Catalog # 0333711...

Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2.

FDADec 9, 2005CA, FL, GA +10 more• Roche Diagnostics Corp.

Philips Medical Systems North America Co. Phillips: Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. S...

The Gyroscan NT MRI system has a computer software problem which results in images from one patient being placed into another patient's image record.

FDADec 9, 2005Nationwide• Philips Medical Systems North America Co. Phillips

Boston Scientific Corp: Boston Scientific brand Microbiology Specimen Brush, sin...

The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing.

FDADec 8, 2005Nationwide• Boston Scientific Corp

Kawasaki Brute Force ATVs – Vehicle Safety Concern (2005)

The recall involves Kawasaki 2005 model year KVF750-A1 and KVF750-B1 Brute Force ATVs. These models are 750cc V-twin All Terrain Vehicles available in Red, Green, Yellow, and Camouflage colorings. They have "Kawasaki" and "Brute Force" on the sides of the bodywork below the handlebars, and "V-Twin 750" on the sides of the rear fenders.

CPSCDec 8, 2005Nationwide

Bobby Jack Pajama Set – Sleepwear Safety Issue (2005)

The recalled pajama sets include a tank top and a pair of shorts. Made of a polyester and cotton blend, the pajamas were sold in four colors: green, fuchsia, light blue and light pink in sizes extra small through extra large. The pajama tops have a large, rubber decal of one or more monkeys on the front, and the bottoms have a monkey print on them. A label on the inside of the garment reads, "Bobby by BobbyJack."

CPSCDec 8, 2005Nationwide

Abbott Laboratories, Inc: ARCHITECT c8000 System Software, Version 2.11, Product Li...

System software assigns a calibrator default volume of 2.0uL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0 uL.

FDADec 8, 2005Nationwide• Abbott Laboratories, Inc

Smiths Medical MD, Inc.: Large-Volume IV Administration Sets for use with Deltec 3...

Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.

FDADec 8, 2005SC, PR• Smiths Medical MD, Inc.

Chuck E. Cheese Siren Whistle – Choking Hazard (2005)

The recalled plastic siren whistle is a red, green or purple tube with small plastic pieces inside. The whistle is about 2 inches long and ¾ inch wide. The toy whistles were distributed as prizes at Chuck E. Cheese's by redeeming 15 tickets earned by playing games.

CPSCDec 8, 2005Nationwide• Chuck E. Cheese's (CEC Entertainment), of Irving, Texas

Roche Diagnostics Corp.: Roche Elecsys total PSA CalSet, catalog number 11731696322.

There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.

FDADec 7, 2005Nationwide• Roche Diagnostics Corp.

Datascope Corp: Panorama Patient Monitoring Network, Cardiac Arrhythmia M...

Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.

FDADec 7, 2005Nationwide• Datascope Corp

Roche Diagnostics Corp.: Roche Elecsys total PSA, catalog number 11731262322.

There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.

FDADec 7, 2005Nationwide• Roche Diagnostics Corp.

Boston Scientific Corporation: The Flextome Cutting Balloon Device consists of a balloon...

The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.

FDADec 7, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: The Peripheral Cutting Balloon Device small Monorail Deli...

The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.

FDADec 7, 2005Nationwide• Boston Scientific Corporation

Smiths Medical PM, Inc.: Smiths Pneupac babyPAC portable ventilator, model 100. D...

A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose.

FDADec 5, 2005CA, CO, IN +5 more• Smiths Medical PM, Inc.

DVD Home Theater System (Toshiba) – Potential Defect (2005)

This recall involves the Toshiba 5-Disk DVD Home Theater System, model number SD-C67HT. The model number can be found on the front of the DVD Player/Receiver to the right of the word "Toshiba." The DVD Home Theater System consists of six speakers, including a subwoofer and a DVD Player/Receiver.

CPSCDec 5, 2005Nationwide

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