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September 2011 Supplement - vol. 20:12

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.

BAXTER HEALTHCARE CORP., Round Lake, IL. Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Baxter Solution Set with Duo-Vent Spike. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 21st, 2011. Volume in Commerce: 4,752 units. Reason: The position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide 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-2920-2011. FDA Enforcement Report, 8/31/11.

DRAGER MEDICAL SYSTEMS INC., Telford, PA. Infinity Delta / Gamma Portable Patient Monitor. Class II. Firm initiated recall ongoing. Firm notified users by letter in July 2011. Volume in Commerce: 1,076 units. Reason: Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically. FDA recall #Z-3047/3048-2011. FDA Enforcement Report, 9/14//11.

GE HEALTHCARE LLC, Waukesha, WI. GE Healthcare DISCOVERY Model NM/CT 670 NM/CT System. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 26th, 2011. Volume in Commerce: 4 units. Reason: GE Healthcare has become aware of a missing laser aperture warning label (i.e. Laser Aperture – Do Not Stare Into Beam) affecting certain Discovery Systems. FDA recall #Z-2158-2011. FDA Enforcement Report, 8/31/11.

HOSPIRA INC., Lake Forest, IL. Manufacturer: Hospira Inc., Morgan Hill, CA; Hospira Inc., San Diego, CA. Gem-Star Li-Ion Docking Station. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 1st, 2011. Volume in Commerce: 18,000 units. Reason: Hospira has received reports of sparking, smoking, charring and electrical shock when using the GemStar Docking Station due to fluid ingress into the docking station. FDA recall #Z-3107-2011. FDA Enforcement Report, 9/7/11.

INTUITIVE SURGICAL INC., Sunnyvale, CA. Intuitive Surgical da Vinci Si Surgical System (IS3000). Class II. Firm initiated recall ongoing. Firm notified users by telephone on July 1st, 2011. Volume in Commerce: 183 units. Reason: Potential failure of the retention component of the Master Tool Manipulator (MTM) of the Intuitive Surgical da Vinci Si Surgical System which could cause uncontrolled movement. FDA recall #Z-2930-2011. FDA Enforcement Report, 9/7/11.

MCKESSON INFORMATION SOLUTIONS LLC, Alpharetta, GA. Manufacturer: Mckesson Medical Imaging, Richmond British Columbia, Canada. Horizon Medical Imaging. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 13th, 2011. Volume in Commerce: 438 devices. Reason: Images for one patient may appear in the study of another patient. FDA recall #Z-3035-2011. FDA Enforcement Report, 8/31/11.

PHILIPS MEDICAL SYSTEMS, San Jose, CA. Manufacturer: Philips Medical Systems, Cleveland, OH. Philips brand BrightView Gamma Camera System. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 15th, 2011. Volume in Commerce: 461 units. Reason: The gap between the two parts of the table may permit pinches to occur on either patient’s skin or other body parts; it has the potential for serious injury if a patient’s finger is caught between the pallet and patient table resulting in broken finger bone. FDA recall #Z-2867/2872-2011. FDA Enforcement Report, 8/31/11.

PHILIPS MEDICAL SYSTEMS, Cleveland, OH. Vertical Brake Hubs. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 1st, 2011. Volume in Commerce: 412 units. Reason: Philips Medical Systems decided to conduct a recall / field correction of the patient support vertical brake hub component in all of their CT MX8000 Dual v. Exp. Computed Tomography X Ray System scanners due to a component defect which could cause an unexpected downward motion of the table (couch) while the patient is on the table. This event could occur because the short key connecting the vertical brake hub to the motor shaft can become disengaged due to the lack of thread locker on the set screws. FDA recall #Z-2914-2011. FDA Enforcement Report, 8/31/11.

PHILIPS HEALTHCARE INC., Andover, MA. 865047 IntelliVue Clinical Information Portfolio Release. Class II. Firm initiated recall ongoing. Firm notified users by letter in July 2011. Volume in Commerce: 454 units. Reason: Under certain circumstances, edits to an order can result in unintended scheduled interventions on the IntelliVue Clinical Information Portfolio. A patient may receive interventions or additional medication doses that are not intended. FDA recall #Z-3111-2011. FDA Enforcement Report, 9/7/11.

PHILIPS HEALTHCARE INC., Andover, MA., Manufacturer: Philips Medical System Nederlands, Best, Netherlands. Allura Xper Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 4th, 2011. Volume in Commerce: 1,423 units. Reason: System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period. FDA recall #Z-2976-2011. FDA Enforcement Report, 8/31/11.

SIEMENS MEDICAL SOLUTIONS USA, INC. Malvern, PA. Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Siemens MAGNETOM Systems. Firm notified users by letter on March 31st, 2011. Volume in Commerce: 440 units. Reason: Firm has discovered during product monitoring that on a few systems the gradient and benign diseases. Model No. H48. FDA recall #Z-2786-2011. FDA Enforcement Report, 8/31/11.

STERIS CORP., Mentor, OH. Manufacturer: Steris Mexico, Guadalupe, Mexico. Amsco V-Pro 1/Plus Low Temperature Sterilization Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 5th, 2011. Volume in Commerce: V-Pro 1: 512 units; V-Pro 1 Plus: 151 units. Reason: Users may experience premature wear of the vacuum pump and filtering assembly components. Users may also experience incomplete aeration of the device’s chamber following a failed leak test. FDA recall #Z-3041-2011. FDA Enforcement Report, 8/31/11.

SUNRISE MEDICAL HHG INC. DBA DEVILBISS HEALTHCARE. Somerset, PA. DeVilbiss Model DV5x Series CPAP. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 11th, 2011. Volume in Commerce: 210 units. Reason: Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture. FDA recall #Z-2990-2011. FDA Enforcement Report, 8/31/11.

TISPORT LLC., Pasco, WA. TiLite Mechanical Wheelchairs. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 5th, 2011. Volume in Commerce: 1,037 units. Reason: The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off. FDA recall #Z-3161-2011. FDA Enforcement Report, 9/14/11.

VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS, Palo Alto, CA. High-Definition 120 Multileaf Collimator. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 6th, 2011. Volume in Commerce: 173 units. Reason: When using the HD120 Multileaf Collimator for beam shaping, and under specific conditions, dose may be delivered outside the intended treatment field that exceeds the expected transmission dose. FDA recall #Z-3052-2011. FDA Enforcement Report, 9/14/11.

VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS, Palo Alto, CA. Varian Treatment. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 20th, 2011. Volume in Commerce: 118 units. Reason: Potential for Varian Treatment applications failing to load the physical wedge filter for a treatment field on Siemens Mevatron linear accelerator. Delivery of a treatment field without the planned wedge would deliver more dose than intended and would change the shape of the dose distribution for that field. FDA recall #Z-3105-2011. FDA Enforcement Report, 9/14/11.

VITAL SIGNS DEVICES, A GE HEALTHCARE CO., Totowa, NJ. enFlow IV Fluid Warmer. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 30th, 2011. Volume in Commerce: 1,307 units. Reason: enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer. FDA recall #Z-3040-2011. FDA Enforcement Report, 8/31/11.