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Showing 62941–62960 of 68218 results

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Chattanooga Corp Inc: INTELECT LEGEND XT, Model No. 2763, Chattanooga Group, Hi...

Device malfunction: causing electric shock and burn.

FDADec 17, 2007Nationwide• Chattanooga Corp Inc

Viasys Respiratory Care, Inc.dba Bird Products: VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Co...

Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.

FDADec 17, 2007AL, CA, MA +3 more• Viasys Respiratory Care, Inc.dba Bird Products

GE Healthcare: GE Healthcare Definium 5000 Digital Radiographic Imaging ...

GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.

FDADec 17, 2007AZ, CA, FL +5 more• GE Healthcare

Cook Vascular Inc.: Flexipet Manipulation Pipette 300 micron. The product is ...

mislabeled - 300 micron flexipets were labeled as 80 microns

FDADec 17, 2007IN, MD, NJ +1 more• Cook Vascular Inc.

Chattanooga Corp Inc: INTELECT ADVANCED, Model No. 2752CC, Chattanooga Group, H...

Device malfunction: causing electric shock and burn.

FDADec 17, 2007Nationwide• Chattanooga Corp Inc

Chattanooga Corp Inc: VECTRA TRANSPORTABLE, Model No. 2783, Chattanooga Group, ...

Device malfunction: causing electric shock and burn.

FDADec 17, 2007Nationwide• Chattanooga Corp Inc

Biosense Webster, Inc.: EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Dir...

The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009.

FDADec 15, 2007Nationwide• Biosense Webster, Inc.

Smiths Medical MD, Inc.: Smiths CADD Medication Cassette Reservoirs with Clamp and...

Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps

FDADec 14, 2007AL, AK, AZ +48 more• Smiths Medical MD, Inc.

Pointe Scientific, Inc.: Pointe Scientific Liquid ALT (SGPT) reagent set for the q...

Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.

FDADec 14, 2007Nationwide• Pointe Scientific, Inc.

GE Healthcare: GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR ...

GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.

FDADec 14, 2007AL, AZ, CA +33 more• GE Healthcare

GE Healthcare: GE 1.5T and 3.0T Signa HDx MR System The product is use...

GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.

FDADec 14, 2007AL, AZ, CA +33 more• GE Healthcare

Smiths Medical MD, Inc.: Smiths CADD Yellow Medication Cassette Reservoirs with Cl...

Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps

FDADec 14, 2007AL, AK, AZ +48 more• Smiths Medical MD, Inc.

OEC Medical Systems, Inc: GE Healthcare OEC 9900 mobile fluoroscopic x-ray system

Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default selection to another selection. Manual technique modes are not affected.

FDADec 14, 2007Nationwide• OEC Medical Systems, Inc

Lifesync Corporation: LS-202 Large LeadWear Combo Pack - Disposable ECG Monitor...

LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-232 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a V-Lead failure, intended for use as a radiofrequency signal transmitter and receiver of electrocardiograph physiological signals which are displayed on the ECG monitors of various manufacturers' systems that have been

FDADec 13, 2007Nationwide• Lifesync Corporation

Given Imaging Inc: Given Diagnostic System with PillCam SB Capsule - Gastroi...

The cards included in the product's education kit (proposing a clinical algorithm for capsule endoscopy in patients with suspected Crohn's disease), were printed incorrectly.

FDADec 13, 2007PR• Given Imaging Inc

VISX INCORPORATED, A SUBSIDIARY OF AMO INC: AMO VISX STAR Excimer Laser System, manufactured by VISX,...

Firm received two complaints (including one injury complaint) associated with the movement of the VISX chair while in the patient loading ("fully swung out" unlocked) position under an IntraLase FS laser.

FDADec 13, 2007AL, AK, AZ +47 more• VISX INCORPORATED, A SUBSIDIARY OF AMO INC

GE Healthcare: S/5 iCentral, Cardiovascular Monitoring Devices, Versions...

Failure to alarm: An active monitor could become disconnected from the unit without any notification or alarm.

FDADec 13, 2007AZ, CA, CO +27 more• GE Healthcare

Lifesync Corporation: LS-232 Large 12 LeadWear Single Pack - Disposable ECG Mon...

LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-232 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a V-Lead failure, leading to a possible delay in treatment based upon a delay in ECG monitoring.

FDADec 13, 2007Nationwide• Lifesync Corporation

Philips Medical Systems North America Co. Phillips: DigitalDiagnost X-ray System is a stationary Diagnostic X...

When using DICOM print functionality, the printed images may contain data for the wrong patient.

FDADec 13, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Biomet, Inc.: Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 14123...

Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.

FDADec 12, 2007GA, ID, IN +3 more• Biomet, Inc.

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