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Showing 66401–66420 of 68218 results

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MEDIVANCE INC.: Arctic Sun Temperature Management System

Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.

FDAJan 5, 2005AL, AZ, CO +18 more• MEDIVANCE INC.

Warsaw Orthopedic, Inc.: ATLANTIS Element Express Kit; a sterile kit for cervical ...

The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.

FDAJan 4, 2005Nationwide• Warsaw Orthopedic, Inc.

Plus Orthopedics: UltraCongruent Tibial Insert Model 0214703 Tibial Insert...

Knee tibial insert is mislabeled completely as different device.

FDAJan 4, 2005CA, ID, IL +2 more• Plus Orthopedics

Power Surgical Solutions: Medtronic Midas Rex Legacy Telescoping Dissection Tool, M...

Device is missing the sub-collet component within the dissecting tool package.

FDAJan 3, 2005CA, IN• Power Surgical Solutions

Maquet Inc: Servo-Ventilator, SV300/300A, Part numbers 6070391 and 64...

Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.

FDAJan 3, 2005Nationwide• Maquet Inc

Northwest Medical Physics Equipment Inc: ISOLOC Software Version 6.0, Part Number NT-NW-425-520. ...

When ISOLOC version 6.0 software was used in the Anatomic Landmark mode, the couch moves display in the Couch Translator window was incorrect.

FDADec 30, 2004Nationwide• Northwest Medical Physics Equipment Inc

General Electric Med Systems LLC: Precision 500D Radiographic/Fluoroscopic X-ray System, mo...

Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.

FDADec 30, 2004Nationwide• General Electric Med Systems LLC

General Electric Med Systems LLC: Proteus XR/a Radiographic X-ray System, models 2259973-1,...

Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.

FDADec 30, 2004Nationwide• General Electric Med Systems LLC

Hill-Rom, Inc.: Hill-Rom brand VersaCare Bed; product P3200.

A potential trip hazard exists when the fracture frame adaptor bracket is installed on the bed without the fracture frame.

FDADec 29, 2004Nationwide• Hill-Rom, Inc.

Stryker Endoscopy: Stryker brand Bioabsorbable ACL Interference Screw, 10mm ...

The label on the outside of the shipping box has an incorrect description of the screw diameter.

FDADec 27, 2004Nationwide• Stryker Endoscopy

Baxter Healthcare Renal Div: HomeChoice PRO Automated Peritoneal Dialysis Systems; Man...

A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products.

FDADec 23, 2004IN• Baxter Healthcare Renal Div

Diamedix Corporation: The Is-Legionella IgG/IgM/IgA test kits are packaged in c...

Laceration Risk

The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges.

FDADec 23, 2004Nationwide• Diamedix Corporation

Fisher & Paykel Healthcare Inc: RT130 and RT131 Neonatal/ Infant Breathing Circuits, heat...

Pressure elbow may be partly occluded.

FDADec 21, 2004Nationwide• Fisher & Paykel Healthcare Inc

Roche Diagnostics Corp.: Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for...

A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.

FDADec 21, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand ISE SnapPak for use only in the AVL 9120/9130...

A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.

FDADec 21, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, f...

A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.

FDADec 21, 2004Nationwide• Roche Diagnostics Corp.

Philips Medical Systems Sales & Service Region No. America: Xcelera R1.2 Cardiology image and information management ...

Loss of image data from image repository and archive requiring patients to undergo repeat imaging.

FDADec 21, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

Roche Diagnostics Corp.: Vital Scientific brand ISE Snap Pack for use only in the ...

A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.

FDADec 21, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pac...

A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.

FDADec 21, 2004Nationwide• Roche Diagnostics Corp.

Cook, Inc.: Cook brand Zenith Flex AAA Endovascular graft with the H&...

The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.

FDADec 20, 2004Nationwide• Cook, Inc.

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