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July 20, 2010 vol. 19:11

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.

FDA Posting 7/20/10: CONSTELLATION Vision System: Recall

Alcon Research LTD doing business as Alcon Laboratories, Inc. - CONSTELLATION Vision System

Recall Class: Class I

Date Recall Initiated: April 30, 2010

Product: CONSTELLATION Vision System; Use: The Alcon CONSTELLATION Vision System is an ophthalmic microsurgical system used by eye surgeons to perform various types of eye surgery.

ALL model and catalog numbers are affected by this recall. These devices were manufactured and distributed from September 1, 2008 through April 30, 2010.

Product Model

Catalog Number

Constellation Vision System with Laser

8065751145

Constellation Vision System Without Laser

8065751147

Constellation Tabletop

8065751150

Constellation XT

8065751548

Constellation LT

8065751549

Constellation LXT

8065751550

Constellation LX

8065751551

Constellation B

8065751552

Constellation X

8065751553

Constellation L

8065751554

Constellation T

8065751558

Reason for Recall: Alcon initiated the recall after it identified both software and hardware problems which have been associated with unexpected system loss of power (shutdowns), unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems. These events may cause eye injuries, including blindness.

Public Contact: For assistance and questions regarding the CONSTELLATION Vision System, customers may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.

FDA Comments: On July 2, 2010, Alcon sent its customers an "Urgent Medical Device Recall" letter to all its CONSTELLATION users. The letter informed customers about the potential problem and stated that Alcon representatives will visit ALL U.S. facilities to update the software, replace the touchscreen circuit board, and to answer any questions. This recall will not require the removal of the CONSTELLATION Vision System from any healthcare facility.

BIOSITE, INC., San Diego, California. Triage Profiler Controls: a) Triage Total Controls 5 level 1; b) Triage Total Controls 5, Level 2; 3) Triage Total Controls Calibration Verification 5. Class II. Firm initiated recall is complete. Firm notified users by letter dated February 6, 2009. Volume in Commerce: 1,738 units. Reason: Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field. FDA recalls #Z-1788/1790-2010. FDA Enforcement Report, 07/21/10.

GE HEALTHCARE, LLC, Waukesha, Wisconsin: Manufacturer: GE Medical systems, SCS, Buc Cedex, France. Radiology Innova Systems: for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures: a) Innova 2100IQ with InnovalQ Table Option; b) Innova 3100/3100IQ with InnovaIQ Table Option; c) Innova 4100/4100IQ with InnovaIQ Table Option. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated May 12, 2010. Volume in Commerce: 92 units. Reason: GE Healthcare has become aware of a potential loss of gantry and table motions that affect the listed systems and may impact patient safety. FDA recalls #Z-1921/1923-2010. FDA Enforcement Report, 07/21/10.

HAAG-STREIT USA, INC., Mason, Ohio: Manufacturer: Haag Streit Ag, Koeniz, Switzerland. Slit-Lamp: Lenstar LS 900, Biomicroscope. Class II. Firm initiated recall is ongoing. Firm notified users by letter beginning May 19, 2010. Volume in Commerce: 45 units. Reason: During the creation of the Lenstar LS 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for US distribution. The current software installed allows the user to manually alter the retinal thickness measurement, which could modify the automatic axial eye length measurement resulting the selection of an incorrect intra-ocular lens (IOL). FDA recall #Z-1897-2010. FDA Enforcement Report 07/21/10.

MALLINCKRODT, INC., Cincinnati, Ohio: Manufacturers: Sedecal USA, Inc., Arlington Heights, Illinois; Sedecal S.A., Algete, Spain. Hydradjust IV DR Urological Table Generator: a) part # 750732 – 64 W generator; b) part # 750733 – 80 W generator. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated June 14, 2010. Volume in Commerce: 144 units. Reason: Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator becoming inoperative. FDA recall #Z-1904-2010. FDA Enforcement Report, 07/21/10.

PHILIPS MEDICAL SYSTEMS, Seattle, Washington. Defibrillator - AED: a) HeartStart FRx; b) HeartStart HS1 OnSite; 3) HeartSmart HS1 Home. Class II. Firm initiated recall is ongoing. Firm notified users by telephone, email, and website posting on April 30, 2010 and by letter dated April 29, 2010. Volume in Commerce: 458 units. Reason: Seventeen AEDs failed production line testing (Final Acceptance Testing). FDA recalls #Z-1915/1917-2010. FDA Enforcement Report, 07/21/10.

RESPIRONICS, INC., Murrysville, Pennsylvania. Ventilator: Trilogy 100 Ventilator. Class II. Firm initiated recall is ongoing. Firm notified users by telephone beginning June 10, 2010. Volume in Commerce: 23 units: California, Florida, Illinois, Montana, New York, North Carolina, & Texas. Reason: It is possible that the battery could electrically short, resulting in a potential fire or a thermal event. FDA recall #Z-1896-2010. FDA Enforcement Report, 07/21/10.

SIEMENS HEALTHCARE DIAGNOSTICS, INC., Los Angeles. IMMULITE 2000/2500 Chemiluminescent Substrate Module for use in the routine operation of the IMMULITE 2000 and 2500 Analyzers. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated May 2009. Volume in Commerce: 41,573 units. Reason: Some substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods. FDA recall #Z-1891-2010. FDA Enforcement Report, 07/21/10.

SPINEMATRIX, INC., Akron, Ohio. Lumbar Matrix Scan Diagnostic Electromyography System. Class II. Firm initiated recall is ongoing. Firm notified users by telephone beginning Jan. 29, 2010. Volume in Commerce: 14 units; 1,152 electrode arrays: California, Ohio Oregon, & Texas. Reason: The design audit in July 2009 revealed numerous design verification tests that either did not pass or did not meet the design input requirement, including the possibility of a physician reviewing one patient’s scan without realizing that it was actually from a different patient. FDA recall #Z-1935-2010. FDA Enforcement Report, 07/21/10.