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Around the MBI Circuit

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

April 2011 - vol. 20:05

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.

ZEVEX INTERNATIONAL, INC., Salt Lake City Utah. Infusion Pumps: 1) Curlin 6000 CMS Ambulatory Infusion Pump; 2) Curlin 6000 IOD Ambulatory Infusion Pump; 3) Curlin PainSmart Ambulatory Infusion Pump; 4) Curlin PainSmart IOD Ambulatory Infusion Pump. Class I. Firm initiated recall ongoing. Firm notified users by letter dated February 28, 2011. Volume in Commerce: 18,306 pumps. Reason: Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed. FDA recalls #Z-1867/1870-2011. FDA Enforcement Report, 04/13/11.

ARJO INC., dba ArjoHuntleigh, Addison, Illinois: Manufacturer: Rolko Kohgruber Gmbh, Borghalzhausen, Germany. Adjustable Strap and Handle: accessory component to long term care hospital beds. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 24, 2011. Volume in Commerce: 41 units. Reason: Part of the housing of the strap retracting mechanism built into the handle may break while the patient is using the handle and strap. FDA recall #Z-1933-2011. FDA Enforcement Report, 04/20/11.

CINCINNATI SUB-ZERO PRODUCTS, Cincinnati, Ohio. Hyper/Hypothermia System, Blanketrol III: a) Model 233, Part number 86107; b) CoolBlus Model 25-01, part number 86000. Class II. Firm initiated recall ongoing. Firm notified users by letter dated October 2010. Volume in Commerce: Module 233 - 763 each; CoolBlue - 133 each. Reason: The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device’s operation and Operation/Technical Service Manual in order to stay in compliance with labeling regulations. FDA recall #Z-1817-2011. FDA Enforcement Report, 04/13/11.

GE HEALTHCARE, LLC, Waukesha, Wisconsin : Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. GE CARESCAPE Monitor B850. Class II. Firm initiated recall ongoing. Firm notified users by letters dated March 23, 2011. Volume in Commerce: 8,345 units. Reason: GE Healthcare has become aware of a potential safety issue associated with the CARESCAPE Monitor B650 & B850 Cardiac Output measurement using Patient Data Module (PDM), and activation of ECG Leads Off alarm in specific cases. 1. When the CARESCAPE Monitor is used to measure Cardiac Output values with the Patient Data Module (PDM) or TRAM Module, Cardiac Output values may be calculated incorrectly if the default catheter settings are used. This may lead to improper treatment. However, with user-defined catheter settings, the values are calculated correctly. 2. The ECG Leads Off alarm may not be activated with a specific user workflow. This can happen in a workflow where the user chooses to Update Lead Set in the ECG menu, but does not complete the ECG lead placement correctly. There will be a message of Lead Off shown within the monitor ECG waveform display to inform user of a missing lead. If the Lead Off error is not corrected and additional leads are removed or become disconnected, a complete loss of ECG monitoring can occur without activation of any Leads Off alarms. No injuries or illnesses reported. FDA recall #Z-1929-2011. FDA Enforcement Report, 04/20/11.

GE HEALTHCARE, LLC, Waukesha, Wisconsin. GE Senographe Essential Full Field Mammography System Class II. Firm initiated recall ongoing. Firm notified users by letter beginning January 19, 2011. Volume in Commerce: 14 units. Reason: During the installation it was discovered that the duplicate of the 21 CFR 1010 Certification label for the X-ray Generator Cabinet was missing from the installation kits that allow installation of the Senographe Essential in a van (mobile unit). FDA recall #Z-1041-2011. FDA Enforcement Report, 04/06/11.

GE HEALTHCARE, LLC, Waukesha, Wisconsin. GE Senographe Essential Full Field Mammography System 1) Full Field (Seno Essential); 2) Senographe DS Full Field Mammography System Mammographic Film Screen System. Class II. Firm initiated recall ongoing. Firm notified users by letter beginning July 20, 2010. Volume in Commerce: 112 units. Reason: It was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There is a potential that other X-ray tube covers are missing the rating plate. FDA recall #Z-1043/1044-2011. FDA Enforcement Report, 04/06/11.

GE HEALTHCARE, LLC, Waukesha, Wisconsin. Telemetry: ApexPro Telemetry System. Class II. Firm initiated recall ongoing. Firm notified users by letter dated December 29, 2010. Volume in Commerce: 2,346 units. Reason: GE Healthcare has become aware of a potential for loss of patient monitoring when ApexPro Telemetry System is used in conjunction with a mirrored view CARESCAPE CIC Pro in combination monitoring mode (combo mode). The safety issue includes the potential for a delay in enunciation of audible alarms when used in combo mode and may result in the delay of treatment in a cardiac event. FDA recall #Z-1522-2011. FDA Enforcement Report, 04/06/11.

GENDEX DENTAL SYSTEMS, Des Plaines, Illinois. Wall Mounting Plate: accessory to the Gendex Intraoral X-ray Systems. Units distributed between April 12, 2010 and May 13, 2010. Class II. Firm initiated recall ongoing. Firm notified users by letter dated December 20, 2010. Volume in Commerce: 33 units. Reason: The X-ray unit may break loose from the mounting plate and fall off wall due to defects in the mounting plate. FDA recall #Z-1559-2011. FDA Enforcement Report, 04/06/11.

HAMILTON MEDICAL INC., Reno, Nevada: Manufacturer: Hamilton Medical AG, Bonaduz, Switzerland. Hamilton Ventilator G5: with neonatal option. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 16, 2011. Volume in Commerce: 97 units: Florida, Georgia, Massachusetts, Minnesota, Missouri, Texas, and West Virginia. Reason: The adaptive volume/pressure regulation can be automatically and permanently reduced to PEEP + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator. FDA recall #Z-1928-2011. FDA Enforcement Report, 04/20/11.

LINVATEC CORPORATION, dba ConMed Linvatec, Largo, Florida: Manufacturer: Gcx Corp., Petaluma, California. Articulating Arm, Secondary Flat Panel: for mounting and position of flat screen monitors. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 17, 2010. Volume in Commerce: 373 units. Reason: If the VHM Arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement. FDA recall #Z-1893-2011. FDA Enforcement Report, 04/13/11.

PHYSIO CONTROL, INC., Redmond, Washington. Defibrillator – Lifepak 12. Class II. Firm initiated recall ongoing. Firm notified users by letter beginning October 1, 2010. Volume in Commerce: 39,180 units. Reason: When a user disconnects the device from AC power with out following operating instructions and pushes the Power ON button within 2 seconds after disconnecting from AC power, the service indicator will illuminate and the device may fail to charge the defibrillator and/or initiate pacing. FDA recall #Z-1548-2011. FDA Enforcement Report, 04/06/11.

SIEMENS MEDICAL SOLUTIONS USA, INC., Mountain View, California. Ultrasound System: Acuson S2000. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 16, 2010. Volume in Commerce: 1,903 units. Reason: Any 2D measurement performed in Exam Review or offline, on a zoomed retrospective clip capture may be erroneous. This applies to 2D, 2D/PW, 2D/CW and 2D/M-mode. FDA recall #Z-1832-2011. FDA Enforcement Report, 04/13/11.

SIEMENS MEDICAL SOLUTIONS USA, INC., Mountain View, California. Ultrasound System: a) Acuson and Sonoline Antares and Antares PE; b)Acuson S2000; c) Acuson X300, X300 PE and Sonovista X300.. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 17, 2010. Volume in Commerce: 4,336 units. Reason: There is an error in the estimation of mean pressure gradient in the cardiac measurement package. The currently implemented calculation will result in an underestimation of the mean pressure gradient (PGmean) when estimated from a trace of the Doppler waveform of the stenotic flow. FDA recalls #Z-1836/1838-2011. FDA Enforcement Report, 04/13/11.

SIEMENS MEDICAL SOLUTIONS USA, INC., Mountain View, California. Ultrasound Transducer: 8V3c used with the Acuson SC2000 Ultrasound System. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 4, 2011. Volume in Commerce: 386 units. Reason: When using the 8V3c transducer in color mode, the derated Ispta 3 (Spatial Peak-Temporal Average Intensity) may exceed the limit stated in the instructions for use. FDA recall #Z-1907-2011. FDA Enforcement Report, 04/20/11.

STERIS CORPORATION, Mentor, Ohio: Manufacturer: Steris Corporation, Montgomery, Alabama. Monitor Arm Adapter: Harmony LA/LED. Class II. Firm initiated recall ongoing. Firm notified users by letter dated February 18, 2011. Volume in Commerce: 15 units. Reason: The arm adapter does not contain labeling specifying the applicable weight and moment limitations of the arm adapter. FDA recall #Z-1886-2011. FDA Enforcement Report, 04/13/11.

ZOLL CIRCULATION, INC., Sunnyvale, California. Zoll Auto Pulse Resuscitation System: cardiac compressor used as an adjunct to manual CPR. Class III. Firm initiated recall ongoing. Firm notified users by letter by telephone on January 2009. Volume in Commerce: 5, 000 units. Reason: Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating. FDA recall #Z-1904-2011. FDA Enforcement Report, 04/20/11.