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QUARTERLY SUMMARY: January - March 2010

A summary of FDA recalls, safety alerts, and manufacturer field corrective actions as reported for the first 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.

ARIZANT HEALTHCARE, INC. Power Cords: nationwide voluntary recall of 100/110-volt power cords attached to its temperature management units and pressure infusion power pack. The affected cords are manufactured by Electri-Cord Manufacturing Corporation of Westfield, Pennsylvania. Reason: The recall is in response to a small number of customer complaints of melting, smoking or fire within the power cord plug. Multiple medical device manufacturers have recently reported power cord concerns to the FDA. The affected power cords may crack and fail at/inside the plug. Vol 19:03.

B. BRAUN MEDICAL, INC. Outlook Pump IV Sets: 49 models. Class II. Reason: System error 9 alarms indicating a potential pressure loss in the pump cassette delivery chamber. This alarm is generated during the pumps' initiation sequence and will not allow the set to be utilized. This requires a new set to be obtained, thus creating a potential for delay in therapy. Vol 19:02.

CARDIAC SCIENCE CORPORATION. Defibrillator: Automated External Defibrillators. Class I. Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a recall. Reason: The automated external defibrillator (AED) may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. Replacement shipments were expected to begin February 15, 2010. Vol 19: 01 & Vol 19:03.

DRAEGER MEDICAL, INC. Monitors: Delta/Delta XL Monitors with Omega S package. Class II. Reason: Monitor is rebooting/resetting. Vol 19:01.

EDWARDS LIFESCIENCES, LLC, Fluid Monitor. Class I. Reason: Reports of clinically significant fluid imbalance. When a certain level of fluid imbalance is detected, the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy. Vol 19:02.

GE HEALTHCARE. Bone Densitometer: 1) IDXA, GE Lunar DEXA, 2) Prodigy 1-8 series, GE Lunar DEXA, 3) DPX-NT series, GE Lunar DEXA, 4) DPX-MD series, GE Lunar DEXA, 5) DPX-Bravo/Duo, GE Lunar DEXA. Class II. Reason: Failure to properly pre-indicate the technique factors to be used during a patient scan. Vol 19:02.

GE HEALTHCARE. C-Arm: 1) GE/OEC 9900 Elite ESP, 2) GE/OEC 9900 Elite GSP. Class II. Reason: Software defect – may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. Vol 19:02.

GE MEDICAL SYSTEMS, LLC. CT Systems Tables: 1) Model # 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi, 2) Model # 2271242 used on LightSpeed 1X through 4X and HiSpeed Qxi, 3) Model # 2269165 used on LightSpeed 1X through 4X and HiSpeed Qxi. Class II. Reason: Failure to provide the certification label required by 21 CFR 1010.2. Vol 19:01.

GE MEDICAL SYSTEMS, LLC. ECG: MAC 800 Resting ECG Analysis System. Class II. Reason: Problems with laser printouts. When more than one ECG report in the file manager is batch printed in laser print, the potential exists for an incorrect patient identification or name to be displayed on the print out. Vol 19:02.

GE MEDICAL SYSTEMS, LLC. Imaging Tables: 1) Omega IV and Omega V on GE Advantx-E, 2) Omega IV and Omega V tables on Innova 2100IQ, 3) Omega IV and Omega V tables on Innova 3100/3100IQ, 4) Omega IV and Omega V tables on Innova 4100/4100IQ, 5) Omega IV and Omega V tables on Innova 2000, 6) Omega IV and Omega V tables on Innova 2121-1Q/3131-1Q. Class II. Reason: An unintended table rotation while the table is locked could lead to a patient fall if the unintended motion occurs during patient transfer. Vol 19:02.

GE MEDICAL SYSTEMS, LLC. Innova Bi-Plane Cardiovascular Systems. Class II. Reason: Switch failure may impact patient safety. The failure could occur due to collision between the lateral plan of Innova Positioner and other equipment in the room. This collision may break the x-ray and positioning switches, and may not allow exam completion. To date, no injury has been reported related to this condition. Vol 19:01.

GE MEDICAL SYSTEMS, LLC. Ultrasound – Voluson E6, E8, and E8 Expert. Class II. Reason: Incorrect operating procedure may impact patient safety. Vol 19:02.

GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHNOLOGY. Telemetry – GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software). Class II. Reason: Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator's Manual may impact patient safety. Vol 19:02.

HETTICH INSTRUMENTS MANAGEMENT. Centrifuge. 1) Mikro 12-24 Centrifuge with 2050 Rotor, 2) Haematokrit 24 with 2050 Rotor, 3) Mikro 20 with 2076 Rotor, 4) Haematokrit 20 with 2050 Rotor. Class I. Reason: Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge. FDA recalls #Z-0612/0615-2010. FDA Enforcement Report, 02/03/10. Vol 19:02.

HILL-ROM, INC. Birthing Beds. Class II. Reason: The brakes may not hold or lock. Vol 19:01.

HOSPIRA, INC. AC Power Cords: shipped between 06/2005 and 5/2009. These cords were used on the following pump models: Nutrimix, Q-Vue, Q2, Q2 Plus, PCA, PCA II, PCA 3, Lifecare PCA, Lifecare 4100, Plum XL, Plum XL3, Plum XL3M, Plum XL3D, Plum A+/Plum 3, and Gem Star Docking Stations plus an additional 23 Hospira systems & models. Class II. Reason: Fire/shock hazard – a component used in the device may cause sparks/flashes and poses a fire and shock hazard. Vol 19:03.

IMAGING SCIENCES INTERNATIONAL. Dental X-Ray: i-Cat Classic, 3D Dental Imaging System. Class II. Reason: Overhead carriage drops quickly. Vol 19:01.

INVACARE CORPORATION. Wheelchair. Invacare Storm TDX SR Power Wheelchair with Stability Lock. Class II. Reason: If the stability lock does not engage properly the chair may veer to one side, rock forward, drive in an unintended circular motion, or fall forward or to one side with a risk of injury to the user. Vol 19:02.

KCI USA, INC. AC Power Cords: used with Low Air Loss Therapy: 1) Kinair IV, 2) Triadyne, 3) Therapulse ATP/II, 4) Kinair Medsurg, 5) Kinair Medsurg Pulse, 6) Tricall, 7) First Step, 8) Plexipulse, 9) Activac, 10) InfoVAC. Class II. Reason: Power cords may crack and fall inside plug with potential for fire. Vol 19:02.

LIFESCAN, INC., OneTouch SureStep Test Strips. LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. Reason: The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL. Vol 19:03.

MAQUET, INC. Surgical Lights. Class II. Reason: Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm. Vol 19:03.

MAQUET, INC. Ventilators: 1) Servo 300/300A (SV300) Siemens – Elema AB; 2) Servo SV900C/D/E (SV900) Siemens – Elema AB. Class II. Reason: Some Servo Ventilators 300/300A and Servo Ventilators 900C/D/E should not be used with a system that may generate negative pressure below 100cm H2O (closed system suctioning) due to the risk of damaging the ventilator's pressure transducers. Vol 19:01.

MEDTRONIC SOFAMOR DANEK USA, INC. Midas Rex Legend Footed Attachment: AF01 for use with all Legend and Legend EHS motors. Class II. Reason: Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use. Vol 19:01.

PHILIPS HEALTHCARE INC. Fetal Monitors: 1) Avalon Fetal Monitor FM 20, 2) Avalon Fetal Monitor FM 30, 3) Avalon Fetal Monitor FM 40, 4) Avalon Fetal Monitor FM 50. Class II. Reason: Potential for inaccurate ultra-sound derived fetal heart rate readings leading to inaccurate clinical decisions. Vol 19:02.

PHILIPS HEALTHCARE INC. Defibrillator/ Monitor: HeartStart MRx/MRxE. Class II. Reason: Incorrect default configuration settings, insufficient battery power as the user may not be alerted that no battery is installed of that a low battery conditions exists prior to discontinuance from AC or DC power. Vol 19:03.

PHILIPS HEALTHCARE INC. Patient Monitors: 1) SureSigns Patient Monitors (VM3, VM4, VM6, VM8), 2) SureSigns Vital Signs Monitors (VS3) – Vital Signs Viewer Central Viewer Station View up to 12 VM Monitors, 3) SureSigns Vital Signs Viewer (VSV); Spot Check Vital Signs Monitor. Class II. Reason: Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker. Vol 19:02.

SMITHS MEDICAL ASD, INC. Infusion Pumps: 1) Medfusion Model 3500 syringe infusion pump, 2) Medfusion model 3010a syringe infusion pump. Class II. Reason: Increased trend of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm messages. If a MNR/MRE alarm message event occurs during start up or during infusion, the pump will provide a visual and audible alarms and the pump will not operate. Vol 19:02.

STATSPIN, INC., doing business as IRIS Sample Processing, Westwood, Massachusetts. Centrifuge: StatSpin Express 4 Model #510 manufactured and distributed from November 2007 through January 2010. Class I. Reason: The rotor of the centrifuge may break and separate from the motor, striking a safety microswitch so it fails to shut down the centrifuge. The loose rotor may strike the lid of the centrifuge housing which may cause the lid to open and eject pieces of the rotor. These pieces may cause serious physical injury to bystanders and may expose them to blood-borne infectious micro-organisms. Vol 19:03.

STERIS CORP. Surgical Lights: Harmony LL 500/700, vertical spring-loaded arm. Class II. Reason: Four reported international cases received where a welded seam at the joint of the spring-loaded arm of the Drger SOLA 500/700 broke as a result of a crack that developed over time. The Steris Harmony LL 500/700 surgical light is a Private Label version of the Drger SOLA 500/700 surgical light. Vol 19:03.

STERIS CORP. Harmony LA, LC 500 and LA 700 Surgical Lighting and Media System. Firm notified users by written notice February 23, 2010. Steris will also contact user/facilities to complete an upgrade to prevent loose wires and/or overheating. Urgent Field Correction. Reason: Some customers may experience premature bulb failures due to loosening of wires and overheating of the lamp housing assemblies. In the event of a primary bulb failure, a secondary lamp is automatically activated. Steris refers users to the Operator Manuals and the following recommendations: Do not touch the glass portion of the lamp with bare fingers as this can cause deterioration of material leading to possible failure of the bulbs; Use only Steris replacement bulbs; and Place the lighting system into STANDBY or OFF mode when not in use. Vol 19:03.

TELEFLEX MEDICAL Hudson RCI One-Way Valve. Class II. Reason: Incorrect packaging. The valve may be placed in the circuit in the wrong orientation for gas flow. Vol 19:02.

TELEFLEX MEDICAL Oxygen Sensor. Class II.Reason: Sensor causes the oxygen to display prematurely a Low Sensor warning which indicates an early maintenance requirement for the instrument. This may result in interrupted treatment. Vol 19:02.

ZAP LASERS LLC. Dental Laser: SoftLase Pro Dental Lasers. Class II. Reason: Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an emission delay, user guide labels and locations, and calibration procedures and schedules. Vol 19:02.

ZOLL MEDICAL CORPORATION. Zoll R Series Defibrillator/Pacemaker/Monitor. Class II. Reason: Failure of device to display ECG could delay delivery of defibrillation or pacing therapy. Vol 19:01.