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

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Modern Biomedical

“Modern has the ability to understand and fulfill our clients needs while meeting and exceeding their expectations. A customers expectation of equipment readiness is met through combining a quick response with technical expertise to achieve minimal downtime and effective cost containment. In a nutshell, solving problems is what we do. Our clients are able to relax and focus their efforts elsewhere”
– Randy Bullard, President/CEO

August 2011 Supplement - vol. 20:11

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 Med Watch - Shoulder Flex Massager. Class I Recall – Risk of Strangulation – King International. Posted by FDA on 8/26/11. The ShoulderFlex Massager is a personal massage device designed to provide deep tissue massage to the neck, shoulder and back while the user lies on a flat surface. King International has distributed 11,934 devices since October 18th, 2003. The devices were sold at various stores and online retailers in the United States. FDA notified health professionals and consumers of serious health risks posed by the ShoulderFlex Massager. FDA is aware of reports to the Consumer Product Safety Commission of one death and one near strangulation. These incidents occurred when a necklace and clothing became caught in a piece of the device that rotates during use. Do not use or recommend use of the ShoulderFlex Massager. Dispose of the device components separately so that the massager cannot be reassembled and used.

ANIMAS CORP., West Chester, PA. Animas 2020 Insulin Infusion Pump. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 29th, 2011. Volume in Commerce: 380 units. Reason: Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. The issue may result in the pump displaying a “Replace Battery” alarm not related to the condition of the battery. FDA recall #Z-3017-2011. FDA Enforcement Report, 8/17/11.

BAXTER HEALTHCARE CORP., Round Lake, IL. Manufacturer: Baxter Healthcare SA, Singapore, Singapore. Baxter Colleague CX Infusion Pump. Class II. Firm initiated recall ongoing. Firm notified users by telephone on July 1st, 2011 and by letter on July 6th, 2011. Volume in Commerce: 2 units. Reason: While replacing a defective pump head mechanism and performing calibration, Baxter’s service center may have failed to apply GLYPTOL (a red insulating varnish) on a potentiometer that helps maintain pump accuracy for detecting an air bolus. FDA recall #Z-2853-2011. FDA Enforcement Report, 8/3/11.

CAREFUSION 207 INC., Palm Springs, CA. Manufacturer: Baxter Healthcare Corp., Largo, FL. AirLife Nebulizer Heater. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 15th, 2011. Volume in Commerce: 22,670 units. Reason: Over time the heater can develop a failure mode that results in an internal electrical short. The short can result in smoke and sparks emitted from the device. In the presence of oxygen enriched environments and a fuel source, this failure represents a potential risk of flame. FDA recall #Z-3016-2011. FDA Enforcement Report, 8/17/11.

DENTAL EQUIPMENT LLC., Newberg OR. LuxStar Dental Light. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 24th, 2011. Volume in Commerce: 13,258 units. Reason: Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient. FDA recall #Z-2834-2011. FDA Enforcement Report, 7/27/11.

ELA MEDICAL LLC., Plymouth, MN. Manufacturer: Sorin C.R.M., srl, Saluggia, VC, Italy. Paradym DR and VR. Class II. Firm initiated recall ongoing. Firm notified users by telephone on April 27th, 2011 and letter on May 2nd, 2011. Volume in Commerce: 275 units. Reason: The devices included an incorrect version of the Patient Booklet. The company determined that there is no risk of adverse event associated with this labeling error. FDA recall #Z-2609-2011. FDA Enforcement Report, 8/17/11.

HAEMOSCOPE DIVISION OF HAEMONETICS CORP., Niles, IL. TEG Hemostasis System Level II Control. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 2nd, 2011. Volume in Commerce: 568 kits. Reason: Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude). FDA recall #Z-2742-2011. FDA Enforcement Report, 7/27/11.

HOLOGIC INC., Bedford, MA.. Fluoroscan Mini C-arm. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 25th, 2011. Volume in Commerce: 540 units. Reason: The Flex arm connector to the C-arm can break and the C-arm that is supported by the flex arm may fall down. FDA recall #Z-3015-2011. FDA Enforcement Report, 8/17/11.

INVACARE CORP., ELYRIA, OH. Manufacturer: Invacare Rehabilitation Equipment Co., Ltd. Suzhou, China. JASMINE Full Body (Patient) Lift. Class II. Firm initiated recall ongoing. Firm notified users by telephone on April 8th and 11th, 2011 and by letter on April 18th, 2011. Volume in Commerce: 274 units. Reason: Component Defect. The rear mast connector on certain patient lifts may break. Failure of the rear mast connector, while in use, would result in a patient being dropped, possibly resulting in serious injury or death to the patient or care provider. FDA recall #Z-2741-2011. FDA Enforcement Report, 8/3/11.

MEDRAD INC., Indianola, PA.. Avanta Fluid Management Injection System. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 2nd, 2011. Volume in Commerce: 842 units. Reason: Event was initially intended to be a product enhancement; upgrades were initiated in October 2007. Observance of a possible increase in complaints and adverse event reporting result in the firm issuing “Important Product User Reminder” to remind users of proper procedures for using the system and the need for diligence in reducing air embolism risks. FDA recall #Z-2866-2011. FDA Enforcement Report, 8/17/11.

PHILIPS HEALTHCARE INC., Andover, MA. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Philips Diagnostic Universal X-Ray System: Diagnostic 94, 96 and 97. Class II. Firm initiated recall ongoing. Firm notified users by letter in April 18th, 2011. Volume in Commerce: 52 units. Reason: Updated Instructions For Use: During an examination where the patient is positioned on a rotatable chair with knees pointed to the rear of the system, the patients lower legs or ankles may be injured / broken. FDA recall #Z-2765-2011. FDA Enforcement Report, 8/24/11.

SPACELABS HEALTHCARE LLC., Issaquah, WA. Ultraview Spacelabs Medical Multigas Analyzer: Model 91518. Class III. Firm initiated recall ongoing. Firm notified users by letter on June 20th, 2011. Volume in Commerce: 481 units. Reason: Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited only to the trend table. FDA recall #Z-2902-2011. FDA Enforcement Report, 8/17/11.

W & H DENTALWERK BUERMOOS GMBH, Burmoos, Austria. Arthrex Reciprocating Saw Attachment Type: V-600SR. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 24th, 2011. Volume in Commerce: 409 units. Reason: Reciprocating saw attachment V600, screws can become loose or come off and fall into the surgical wound and may not be noticed due to its small size. FDA recall #Z-2879-2011. FDA Enforcement Report, 8/3/11.

ZIMMER INC., Warsaw, IN. Manufacturer: Zimmer Spine Austin, TX. Pathfinder NXT Closure Top Driver. Class II. Firm initiated recall ongoing. Firm notified users by letter in April 2011. Volume in Commerce: 269 units. Reason: There is an increased risk of rounding or partial rounding of the hex tip on the Closure Top Driver used for insertion, tightening, and final locking during the screw and rod construct assembly. FDA recall #Z-2722/2723-2011. FDA Enforcement Report, 8/3/11.