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Showing 62901–62920 of 68218 results

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Intuitive Surgical, Inc.: da Vinci S Surgical System, Model number IS2000 Revision ...

Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.

FDADec 27, 2007CA, HI, MI +5 more• Intuitive Surgical, Inc.

Wescor, Inc: Osmocoll, COP Control Reference, SS-038, Contents: 6 uni...

Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.

FDADec 26, 2007Nationwide• Wescor, Inc

Organogenesis, Inc.: Organogenesis Apligraf, interactive wound and burn dressi...

Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism.

FDADec 26, 2007Nationwide• Organogenesis, Inc.

Wescor, Inc: Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 u...

Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.

FDADec 26, 2007Nationwide• Wescor, Inc

Bayer Healthcare LLC: Bayer Contour TS blood glucose monitoring system with 10 ...

InaccurateTest Strip Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher.

FDADec 21, 2007Nationwide• Bayer Healthcare LLC

Bayer Healthcare LLC: Bayer Contour TS blood glucose test strips packaged in pa...

Inaccurate Test Strips Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher.

FDADec 21, 2007Nationwide• Bayer Healthcare LLC

BD Biosciences: BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Comp...

Values might not update in statistics views after certain functions are performed in a worksheet.

FDADec 21, 2007Nationwide• BD Biosciences

Siemens Medical Solutions USA, Inc: Leonardo Workstation Picture Archiving and Communication ...

Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.

FDADec 21, 2007Nationwide• Siemens Medical Solutions USA, Inc

Carestream Health, Inc.: Kodak DirectView Model DR 3000 System, Stationary X-ray S...

Unintended Positioner Movement - The U-Arm Positioner starts to move 1) without command from the operator and/or 2) can unexpectedly start movement if the system is powered down and re-energized after a collision has occurred with the Quantum Table.

FDADec 21, 2007Nationwide• Carestream Health, Inc.

OEC Medical Systems, Inc: Vascular Drape, Surgical drape and drape accessories; Ref...

No Premarket Notification: Product does not have FDA 510(k) approval for use.

FDADec 20, 2007Nationwide• OEC Medical Systems, Inc

Seradyn, Inc.: Seradyn QMS Vancomycin reagents, Part Number: 0373589. Se...

False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.

FDADec 20, 2007CA, NY• Seradyn, Inc.

Arjo, Inc.: BHM Medical Scales, 800 lb. scale weight limit; Part Numb...

Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.

FDADec 19, 2007Nationwide• Arjo, Inc.

Abbott Laboratories: White Blood Cell (WBC) Reagent-Part A used with the CELL-...

Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

FDADec 19, 2007AL, AK, AZ +35 more• Abbott Laboratories

Abbott Spine: Comfort T-Handle Hudson Connector with Impactor Cap; Part...

Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.

FDADec 19, 2007AZ, AR, CA +20 more• Abbott Spine

Arjo, Inc.: BHM Medical Scales, 1000 lb. scales weight limit; Part Nu...

Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.

FDADec 19, 2007Nationwide• Arjo, Inc.

Myelotec, Inc.: Myelotec Steerable Video Guided Catheter, 2.7mm, label in...

Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.

FDADec 19, 2007AL, CA, CT +11 more• Myelotec, Inc.

Zimmer Orthopaedic Surgical Products: Pulsavac, Plus Wound Debridement System, Component Kit, C...

Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.

FDADec 18, 2007Nationwide• Zimmer Orthopaedic Surgical Products

Lifescan Inc: LifeScan OneTouch Data Management Software Version 1.0, P...

Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.

FDADec 18, 2007Nationwide• Lifescan Inc

Zimmer Orthopaedic Surgical Products: Pulsavac Hip Kit ,Catalog #00-5150-482-01, 1kit/package, ...

Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.

FDADec 18, 2007Nationwide• Zimmer Orthopaedic Surgical Products

Zimmer Orthopaedic Surgical Products: Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, ...

Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.

FDADec 18, 2007Nationwide• Zimmer Orthopaedic Surgical Products

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