The Commitment Makes The Difference

“Providing quality and cost-effective biomedical equipment services since 1978.”

Around the MBI Circuit

Modern Biomedical

Modern knows a hospital’s success is not only obtained through quality patient care, but the way the patients receive that care. Modern technicians and support staff go above and beyond the call of duty to make sure our clients’ goals are accomplished.

July 2011 - vol. 20:09

FDA Recalls and/or Manufacturer Product Advisories and Field Corrections

Product distribution is nationwide unless otherwise specified. Contact the Home Office in Dallas for additional information. We cannot always include the serial and lot numbers affected by each recall, as both are often extensive. We also include recalls designated as COMPLETE. The “COMPLETE” designation does not guarantee that all users have been contacted – but signifies that FDA had determined that the manufacturer or supplier has completed due diligence to notify users; in addition, all recall information is significant to the repair history of the device and may: a) help clarify a past intermittent problem whose cause could not be fully explained at time of occurrence or b) provide valuable information for consideration during pre-purchase evaluations.

Class I: BECKMAN COULTER INC., Brea, CA: Chemistry Analyzer: Synchron LX20; LX20 PRO; LXi 725. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Class I. Firm initiated recall ongoing. Firm notified users by letter on April 5, 2011. Volume in Commerce: 1,284 units. Reason: Beckman Coulter has received reports of incorrect electrolyte results in Synchron LX systems due to a variety of maintenance related hardware issues. FDA recall #Z-2130/2132-2011. FDA Enforcement Report, 06/22/11.

AGFA CORP., Greenville, SC. Manufacturer: Agfa Gevaert Healthcare Gmbh, Peissenberg, Germany. NX radiographer’s image identification and quality control tool. Class II. Firm initiated recall ongoing. Firm notified users by mail on March 4th, 2011. Volume in Commerce: 775 units. Reason: When a radiographer is working on two open studies on an NX workstation and, in specific situations, a problem image / annotation mix-up can occur on the NX system. FDA recall #Z-2137-2011. FDA Enforcement Report, 7/6/11.

BAXTER HEALTHCARE CORP., Round Lake, IL. Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Baxter Solution Set for Epidural Use. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 31st, 2011. Volume in Commerce: 3,216 units. Reason: The position of the side clamp and roller clamp may have been reversed during assembly. The reversed orientation of the side clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient. FDA recall #Z-2708-2011. FDA Enforcement Report, 07/13/11.

BECKMAN COULTER INC., Brea, CA. Manufacturer: Beckman Coulter, Inc. Miami, FL. UniCel DxH 800 Coulter Cellular Analysis System. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 11th, 2011. Volume in Commerce: 566 units. Reason: The handheld barcode scanner does not read barcode labels using NW7 symbology. Specimens with NW7 labels cannot be read by the handheld scanner. FDA recall #Z-2157-2011. FDA Enforcement Report, 7/6/11.

BECKMAN COULTER INC., Brea, CA. Manufacturer: Beckman Coulter, Inc. Miami, FL. UniCel DxH 800 Coulter Cellular Analysis System. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 11th, 2011. Volume in Commerce: 566 units. Reason: Specimen tubes may fall out of a Type A cassette when the analyzer inverts the cassette in the mixing station, or when an operator manually inverts a cassette. Tubes may break upon impact, causing possible biohazard exposure. FDA recall #Z-2172-2011. FDA Enforcement Report, 7/6/11.

BECKMAN COULTER INC., Brea, CA. Manufacturers: Beckman Coulter, Inc. Brea, CA; Ids Co.,Ltd., Kumamoto, Japan AutoMate TM Sample Processing System Class II. Firm initiated recall ongoing. Firm notified users by letter on May 7th, 2009. Volume in Commerce: 5 units Reason: It was confirmed that during recovery from Error 81201001, a stuck sample carrier with a tube is moved backwards to the loading position, sample tube / input tray information will become mismatched for samples being loaded onto the AutoMate. FDA recall #Z-2212-2011. FDA Enforcement Report, 7/6/11.

BIOSITE INC DBA INNOVACON, San Diego, CA. Cholestech LDX Lipid Profile GLU test cassettes.Class II. Firm initiated recall ongoing. Firm notified users by February 18th, 2011. Volume in Commerce: 5,305 boxes. Reason: Error in the encoding of calibration coefficients in the sample cassette that cause the Cholestech LDX analyzer to report glucose values as >500 mg/dl regardless of the true value of the specimen. FDA recall #Z-2402-2011. FDA Enforcement Report, 06/22/11.

CINCINNATI SUB ZERO PRODUCTS, INC., Cincinnati, OH. ECMO Heater Model 333 and 333W; Cardiopulmonary bypass temperature controller. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 2nd, 2011. Volume in Commerce: 369 units. Reason: The probe jack contacts (terminals) on certain of the firm’s ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occurs, the service technician, user, and /or patient could be exposed to electric shock during servicing and/or use. FDA recall #Z-2720-2011. FDA Enforcement Report, 7/13/11.

GE HEALTHCARE IT, Barrington, IL. GE Centricity Lab Instrument Interface to Data Innovations InstrumentManager Software. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 3rd, 2011. Volume in Commerce: 14 units. Reason: The GE Centricity Lab Instrument Interface to Data is processing a preliminary result instead of the final result from the Process System Manager when there is a test rerun conducted. FDA recall #Z-2563-2011. FDA Enforcement Report, 06/22/11.

GE HEALTHCARE, LLC, Waukesha, WI. Precision 500D X-Ray systems with under table collimator. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 10th, 2010. Volume in Commerce: 440 units. Reason: Use of high force when moving the image carriage / IDD into forward / park position can cause changes to the mechanical alignment of the collimator blades and allow the blades to open wider then specified, allowing radiation outside the permitted field without warning to the user. This issue manifests with symptoms wherein the user cannot fully close down the lateral blades. FDA recall #Z-1971-2011. FDA Enforcement Report, 7/6/11.

GE HEALTHCARE, LLC, Waukesha, WI. Manufacturer: Vital Signs Inc., Totowa, NJ. Infusable and Infuscan Single Patient Use Pressure Infusors. Firm initiated recall ongoing. Firm notified users by letter on February 25th, 2011. Volume in Commerce: 954,888 units. Reason: Infusable and Infuscan Pressure Infusors may leak and not apply desired pressure to their IV solution bag and subsequently the rate of infusion may be inadequate. FDA recall #Z-2663-2011. FDA Enforcement Report, 7/13/11.

INTEGRA LIMITED, Plainsboro, NJ Manufacturer: Integra Lifesciences (Ireland) Limited; Integra Radionics Inc., Burlington MA. CUSA NXTUltrasonic Tissue Ablation System Service Module Class II. Firm initiated recall ongoing. Firm notified users by letter on May 2nd, 2011. Volume in Commerce: 105 units. Reason: The insulated covering of a wire cable that powers the vacuum pump in the CUSA NXT Service Module can be abraded over time resulting in the exposure of bare wire. If the bare wire were to come in contact with the metal surface of the pump it could result in a short circuit and loss of aspiration. FDA recall #Z-2585-2011. FDA Enforcement Report, 07/13/11.

PHILIPS HEALTHCARE INC., Andover MA. Philips SureSigns VM Series Patient Monitors. Class II. Firm initiated recall ongoing. Firm notified users by letter in May 2011. Volume in Commerce: 5,740 units. Reason: Speakers on the SureSigns Patient Monitors and Vital Signs, failure may be identified by the display of a Speaker malfunction message in the alarm message area or an AUDIO FAILED message in the main screen of the device or by the absence of audible sound. FDA recall #Z-2583/2584-2011. FDA Enforcement Report, 06/22/11.

PHILIPS MEDICAL SYSTEMS, San Jose CA. Brightview XCT Camera. Class II. Firm initiated recall ongoing. Firm notified users in April 2011. Volume in Commerce: 50 units. Reason: The current Headholder to support Bright View XCT brain imaging allowed for imaging the brain but doesn’t allow for imaging of the associated shoulder / neck area of the body. FDA recall #Z-2155/2156-2011. FDA Enforcement Report, 07/06/11.

PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD., Shentang, Liaonoing, China. NeuViz 16 Multi-Slice CT Scanner Class II. Firm initiated recall ongoing. Firm notified users by letter on February 9th, 2011. Volume in Commerce: 9 units. Reason: Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image. FDA recall #Z-2241-2011. FDA Enforcement Report, 7/6/11.

RADIOMETER AMERICA INC., Manufacturer: Radiometer Medical, Bronshoj, Denmark. ABL90 FLEX Portable Gas Analyzer System. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 4th and on February 24th, 2011. Volume in Commerce: 533 units. Reason: The current operating software for the ABL90 analyzer does not prevent the further use of the sensor cassette when there is the possibility of iron rich plaque build-up in the reference electrode. If error message is ignored and continues to obtain biased measuring results, this could lead to a clinically serious misinterpretation of the results and possible misdiagnosis in the critical care setting. FDA recall #Z-2112-2011. FDA Enforcement Report, 06/22/11.

SPACELABS HEALTHCARE, LLC, Issaquah, WA. Ultraview SL Patient Monitor. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 1st, 2011. Volume in Commerce: 4470 units (1891 in US). Reason: The circuit that supplies backup power to the modules in the Medical Patient Monitor, Model 91387, is not working. If there is a power interruption, the three minute backup may not be operational and customers may lose any changes they have made to the alarm settings. FDA recall #Z-2134-2011. FDA Enforcement Report, 7/6/11.

SPACELABS HEALTHCARE, LLC, Issaquah, WA. Ultraview SL 91517 Capnography Module. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 12th, 2011. Volume in Commerce: 5,883 units. Reason: Model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. This reset clears the RAM and the module returns to default settings. FDA recall #Z-2573-2011. FDA Enforcement Report, 7/6/11.

STATSPIN, INC., DBA IRIS SAMPLE PROCESSING, Westwood, MA. Statspin Express 4 Centrifuge. Class II. Firm initiated recall ongoing. Firm notified users by letter in August 2010. Volume in Commerce: 1,802 units. Reason: Rotors may fail due to wire spokes breaking. FDA recall #Z-2169-2011. FDA Enforcement Report, 7/6/11.

TERUMO CARDIOVASCULAR SYSTEMS CORP., Ann Arbor, MI. Terumo Cardiovascular Systems Class II. Firm initiated recall ongoing. Firm notified users by letter on April 21st, 2011. Volume in Commerce: 5,582 units. Reason: Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. Presence of Methylene Blus may interfere with the readings from the shunt sensor for the CDI 500 system in a way that would cause inaccurate pH values. FDA recall #Z-2678/2684-2011. FDA Enforcement Report, 7/6/11.

TOSHIBA AMERICAN MEDICAL SYSTEMS INC., Tustin, California. Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Software for SSH-880CV Aplio Artida; Ultrasound. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 6th, 2010. Volume in Commerce: 28 units. Reason: The Flex M software has reversed left and right annotation and post FKEX M measurement error, which may result in incorrect values. FDA recall #Z-2203-2011. FDA Enforcement Report, 06/22/11.