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A summary of FDA recalls, safety alerts, and manufacturer field corrective actions as reported for the third quarter of the year. This information is a snapshot and chronology of the reported events. For additional details refer to the cited volume of original publication or contact the Home Office.

ABBOTT DIABETES CARE, INC.   Glucose Meters:  a) FreeStyle Blood Glucose Meter; b) FreeStyle Flash Blood Glucose Meter.  Class II.  Reason:  The products may encounter display problem, ‘Er 4’ message, during prolonged use when the low battery symbol is displayed.  Vol. 15:10.

ALCON LABORATORIES, INC.  LADARVision Excimer Laser System:  CustomCornea software only. Class II.  Reason:  A software error associated with the use of the Measuring Mode (ruler tool).  Vol. 15:9.

BAYER HEALTHCARE.  ADVIA 2120 Systems:  Reason:  The ADVIA 2120 has reported highly intermittent low results on all primary results.   Vol. 15:11.

BAYER HEALTHCARE.  Automated Clinical Chemistry Analyzer: a) ADVIA 1650 Chemistry System; b) ADVIA 1200 Chemistry System; c) ADVIA 2400 Chemistry System. Class II.  Reason:  Low QC recovery observed immediately following certain assays.  Vol. 15:11.

BAYER HEALTHCARE.   RapidLab® 1200 Systems: a) Model 1245-Blood gases, electrolyte and blood pH test system; b) Model 1265-Blood gases, electrolyte and blood pH test system.   Class II.  Reason:  Invalid Co-Oximeter values.   Vol. 15:11.

BECKMAN COULTER, INC.  FP1000 Cell Preparation System: Software version 1.0.  Class II.  Reason:  During the cleaning cycle performed during the shutdown procedure of the system, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results.    Vol. 15:12.

BECKMAN COULTER, INC.  LH500 Hematology Analyzer: all software versions.   Class II.  Reason:  Beckman has confirmed that erroneous results could be reported when the workstation data base crashes.    Vol. 15:10.

BECKMAN COULTER, INC.  UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems.  Reason:  Incorrect Reagent Status.    Vol. 15:11.

BIOMERIEUX, INC.  OBSERVA R02:  (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D. Class II.   Reason:  Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle IDs.   Vol. 15:9.

CARDINAL HEALTH, 303 INC., DBA Alaris Products, San Diego, California.  Alaris ® SE Pump (formerly Signature® Infusion Pump.  Class I.   Reason:  This recall was initiated because of a potential for over infusion with all models of the Alaris® SE pumps caused by key bounce. Vol. 15:12.

DELPHI MEDICAL SYSTEMS.  IVantage Volumetric Ambulatory Infusion Pump/System.  Class II. Florida. Reason:  Potential for under-infusion without alarm; cassette rollers stop moving, but the pump shaft continues rotating without alarm.  Vol. 15:11.

DISETRONIC MEDICAL SYSTEM. D-TRONplus Insulin Pump Battery Pack. Class I.  Reason:  The battery may turn the pump off without warning due to a design change in the battery.   Vol. 15:12.

EDWARDS LIFESCIENCES.  Edwards Vigilance Monitors:  (Formerly Baxter Vigilance Monitors). Reason:   Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user to this situation. This can result in overheating and thermal damage to the CCO catheter and serious patient injury.   Vol. 15:10.

GE HEALTHCARE.  S/5 Anesthesia Delivery Unit, ADU. Class II.  Reason:  There exists the possibility that the ADU Fresh Gas Control unit (A-FGC1) can shut off during normal handling of the anesthesia machine and result in no anesthetic agent output.   Vol. 15:9.

GENERAL ELECTRIC MED. SYS. ULTRASOUND.  Ultrasound:  Voluson 730 Expert, Voluson 730 Pro, Voluson ProV with software versions 4.0.0., 4.0.1, 4.0.2., 4.0.3, 4.0.4., 4.0.5, 5.0.0, 5.0.1. Class III.  Reason:  In the cardiac measurement section of the device, the calculation of the PF Mean (mean pressure gradient) leads to an erroneous result.   Vol. 15:9.

HAMILTON MEDICAL, INC.  Ventilators: a) RAPHAEL Ventilator, software version 2.2x; b) RAPHAEL Silver Ventilator, software version 2.2xS; c) RAPHAEL Color, software version 2.2xC, 2.2xCU.  Class II.  Reason:  Alarm Failure – Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system.   Vol. 15:10.

INO THERAPEUTICS, INC.  INOvent, Nitric Oxide Delivery System. Class II.  Reason:   The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.  Vol. 15:11.

INVACARE CORPORATION.  Manual Wheelchair, Kuschall’s K3/K4 series: Model Airlite.  Class II.   Reason:  If the users have chosen to install optional anti-tippers on the chair, the anti-tipper as designed may not be able to bear the stress of repeated or quick loads placed on it, causing the bolt to bend or break.    Vol. 15:12.

KIMBERLY-CLARK CORPORATION. Electrodes.  Class II.  Reason:  The tinfoil in the triangle electrodes has the potential to develop cracks, which may hinder electrical flow and product performance during defibrillation.  Vol. 15:10.

LEICA MICROSYSTEMS.  Surgical Microscope:  Leica M520. Class II.  Reason:  Patient Burns – The use of the surgical microscope at high light intensity and short working distances can result in patient burns.   Vol. 15:9.

MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. Defibrillator: LIFEPAK 20 External defibrillator/monitor.  Class II.  Reason:  Devices with V38 system software do not display a “LOW BATTERY: CONNECT TO AC POWER” message when the monitor is on backup (DC) battery power and may shut down without warning.  Vol. 15:12.
MRL, INC. (Welch Allyn).   PIC50 Automatic External Monitors/Defibrillators.  Class I. Reason: A  DEFIB COMM ERROR, which may prevent or unacceptably delay the delivery of therapy, which may fail to resuscitate the patient. This problem occurs because of an intermittent electrical connection within the device.  Vol. 15:9.
PHILIPS MEDICAL SYSTEMS, NORTH AMERICA. Easy Vision Workstation Family. PACS EasyVision / EasyAccess Release 10.1/10.2   Class II.  Reason:  Potential for measurements, lines, texts, etc to be stored incorrectly. Any added arrow will point to the wrong anatomical structure and will make the image useless in combination with reported findings.   Vol. 15:10.

PHILIPS MEDICAL SYSTEMS, NORTH AMERICA. IntelliVue MultiMeasurement Server. (MMS), physiological patient monitoring system;   Model M3001A. Class II.  Reason:   Patient monitor may display inaccurate reading when the disposable SpO2 sensor is not attached.   Vol. 15:12.

PHILIPS MEDICAL SYSTEMS, NORTH AMERICA.  X-Ray System:  a) MD3 X-Ray System; b) MD4 X-Ray System.  Class II.   Reason:  Potential for unexpected table movement.    Vol. 15:10.

RADIOMETER AMERICA, INC.  Analyzers:  a) Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series ; b) Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-800 Series.  Class II.  Reason:   The ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na).    Vol. 15:10.

RADIOMETER AMERICA, INC. D826 Accessory Kit: for single TCPO2 Electrodes for use with the TCM400 Transcutaneous Monitor, Model #D826.   Class II.  Reason:   Excessive Drift – the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations.   Vol. 15:12.

RADIOMETER AMERICA, INC. TCM4 Series Monitoring System: (Base Unit) Model: 391-876 transcutaneous oxygen monitor; Compact Flash cards – Model # 914-698.  Class III.  Reason:   System shut down – When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further.   Vol. 15:12.

RESPIRONICS, INC. NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Class II.  Reason:  Gas input pressures over 62 psi may cause CPAP pressure oscillation.   Vol. 15:9.

RIVERAIN MEDICAL GROUP.  Medical Image Analyzer:  a) RapidScreen RS-2000; b) RapidScreen RS-Digital. Class III.  Reason:  The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0, resulting in a difference of -5.1% in sensitivity and +1.1 in specificity.   Vol. 15:9.

ROCHE DIAGNOSTICS CORP.  ACCU-CHEK Advantage Blood Glucose Meters:  Class II.  Reason:   The meter (s) gives an error message that can actually mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that the test strip may be damaged or test was not performed correctly.  Vol. 15:10.

ROCHE DIAGNOSTICS CORP.  ACCU-CHEK Test Strips:  Class II.    Reason: The drying agent beads, located in the cap, may become loose and fall into the vial. causing the test strips to potentially give incorrect blood glucose test results.   Vol. 15:10.

ROCHE DIAGNOSTICS CORP.  LC Systems:  Class II.  Firm initiated recall ongoing. Firm notified users by letter on July 17, 2006.  Reason:   If the user opens the instrument lid during decontamination, the cycle will stop, but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not.   Vol. 15:10.

ROCHE DIAGNOSTICS CORP.  Roche/Hitachi K Electrode. Reason:  A design change in the electrodes will result in incorrect potassium level results.  Vol. 15:10.

ROCHE DIAGNOSTICS CORP.  Roche/Hitachi K Electrode. Class III.  . Reason:   Expired product (dated 2006.06) was shipped as replacement for recalled product.  Vol. 15:11.

SAMMONS PRESTON ROLYAN. Tables: a) ValueLine Mat Platform; b) Midland Deluxe Mat Platform; c) Midland Deluxe Mat Platform with Adjustable Backrest; Midland Space-Saver Mat Platform; ValueLine Space-Saver Folding Mat Platform..  Class II.  Reason:  Reports of structural failure on the skirt of select tables. The risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced.   Vol. 15:9.
               
SIEMENS MEDICAL SOLUTIONS USA, INC. KinetDx 4.0 Ultrasound Image Management System.  Class III.  Reason:  The cardiologist’s report comments may not be retained due to a software bug.   Vol. 15:10.

SIEMENS MEDICAL SOLUTIONS USA, INC.  3D-I/III Ceiling Stand:  Diagnostic x-ray tube mount. Class II.  Reason:  Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. Risk of injury to operators’ fingers.   Vol. 15:9.

SKYTRON, DIVISION, The KMW GROUP, INC.  Surgical Tables.  Class II.   Reason:   The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop.  Vol. 15:12.
                                                                                                                                                 

SPACELABS MEDICAL INCORPORATED.  Medical 1400 MHz Telemetry System. Class II. Reason:  Potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.   Vol. 15:9.
STERIS CORPORATION.  Sonic Cleaner.  Class II.  Reason:   Smoke, sparking, and fire hazard.   Vol. 15:11.
STRYKER MEDICAL DIVISION OF STRYKER CORPORATION.  Trio Mobile Surgery Platform:  Model Class II.  Reason:  An incorrect pin may have been used during assembly and therefore the device may give way during use.   Vol. 15:9.

TELEFLEX MEDICAL. Green Spec Fiberoptic Laryngoscope Handle: --Stubby/Short.  Class II.  Reason:  Teleflex Medical has identified that the product may malfunction, causing the handle to heat up. There is a potential for the heated handle to burn the user.   Vol. 15:10.

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION.  Advanced Perfusion System 1. Class II.  Reason: The manual roller pump speed control may fail to function/change pump speed.   Vol. 15:11.

VARIAN MEDICAL SYSTEMS, INC.  Clinac C-series Pendant Radiation Delivery System:  All models.  Class II.  Reason:  Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.   Vol. 15:9.

VARIAN MEDICAL SYSTEMS.  Software:  a) GammaMed software program for the GammaMed model 12i radionuclide applicator system; b) GammaMed software program for the GammaMed model 12it  radionuclide applicator system.  Class II.  Reason:  Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients.    Vol. 15:10.

VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS.  Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators.  Class II. Reason:  A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators.   Vol. 15:10.