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Modern Biomedical

May 15, 2010 vol. 19:07

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 Recall Notice: GE Healthcare Aisys and Avance Anesthesia Systems

Company, Product(s): GE Healthcare Aisys and Avance Anesthesia Systems

Recall Class: Class I

Date Recall Initiated: May 10, 2010

Product Names: The affected Anesthesia Systems were distributed between October 9, 2009 and October 29, 2009.

Model Name

Model Number

Lot/Serial Numbers

Aisys

1011-9000-000

ANAN00814, ANAN00815, ANAN00825, ANAN00830, ANAN00831, ANAN00831, ANAN00832, ANAN00833, ANAN00834, ANAN00835, ANAN00836, ANAN00837, ANAN00838, ANAN00839, ANAN00873

Avance

1009-9002-000

ANBN01180, ANBN01187, ANBN01200, ANBN01201, ANBN01211, ANBN01212, ANBN01213, ANBN01220, ANBN01223, ANBN01224, ANBN01250, ANBN01266, ANBN01284, ANBN01285, ANBN01286, ANBN01287, ANBN01288, ANBN01289

Use: The Aisys and Avance Anesthesia Systems are prescription devices used in healthcare settings under the supervision of a physician. They are intended to provide general inhalation anesthesia and ventilation support to a wide range of patients. These devices are intended for volume or pressure control ventilation.

Recalling Firm:

GE Healthcare, LLC
3000 N Grandview Blvd.
Waukesha, Wisconsin 53188-1615

Reason for Recall: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harnesses have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.

FDA Comments: Customers were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

Class I – GE HEALTHCARE, LLC, Waukesha, Wisconsin: Manufacturer: Datex-Ohmeda, Inc., Madison, Wisconsin. Anesthesia Machine and Monitor: 1) Aisys; 2) Avance. Class I. Firm initiated recall ongoing. Firm notified users by letter on March 12, 2010. California, Florida, and Tennessee plus International. Volume of Product in Commerce: 33 devices. Reason: Unanticipated shut-down due to defect that can cause the machine to unexpectedly shut-down, terminating ventilation, anesthetic delivery, and potentially patient monitoring. FDA recalls #Z-1526/1527-2010. FDA Enforcement Report, 05/12/10.

Class I – NELLCOR PURITAN BENNETT, Inc. (dba Coviden Ltd), Boulder, Colorado: Manufacturer: MMJ S.A. de C.V., Juarez, Mexico. Tracheostomy Tubes: 62 specific styles. Class I. Firm initiated recall ongoing. Firm notified users by letter on April 13, 2010. Volume of Product in Commerce: 444,140 units. Reason: Inflatable tubes may leak air, resulting in inadequate ventilation. FDA recalls #Z-1462/1523-2010. FDA Enforcement Report, 05/12/10.

* * * * *

BOSTON SCIENTIFIC NEUROMODULATION CORP., Valencia, California. Bionic Navigator Clinician Programmer: Model SC-7150-4. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated March 19, 2010, Volume in Commerce: 62 units. Reason: Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing a fire hazard and concluded that the battery cells in specific manufacturing lots could be affected. FDA recall #Z-1409-2010. FDA Enforcement Report, 04/21/10.

CAREFUSION, Middleton, Wisconsin. NicoletOne vEEG System. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 3, 2010. Volume in Commerce: 2,984 units. Reason: CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols. FDA recall #Z-1256-2010. FDA Enforcement Report, 04/28/10.

GE HEALTHCARE IT, Barrington, Illinois: Manufacturer: Dynamic Imaging, LLC, Allendale, New Jersey. PACS Software: 1) Centricity PACS-IW Software; 2) Centricity Wed Diagnostic 1.0. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated February 18, 2010. Volume in Commerce: 670 units. Reason: Potential safety issue as use may result in incorrect anatomic orientation markers. FDA recalls #Z-1394/1395-2010. FDA Enforcement Report, 04/21/10.

MINDRAY DS USA, INC., dba Datascope Patient Monitoring, Mahwah. New Jersey. Anesthesia System: Datascope AS3000. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated March 5, 2010. Volume in Commerce: 479 units. Reason: Caster mount may break causing the wheel to fall off and the unit to tip. FDA recall #Z-1313-2010. FDA Enforcement Report, 04/14/10.

MINDRAY DS USA, INC., dba Datascope Patient Monitoring, Mahwah. New Jersey. SmarTemp Probe Covers: for use with reusable temperature probes and monitors. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated December 31, 2009. Volume in Commerce: 33,976 boxes of 20 probe covers each. Reason: Covers may contain microscopic holes in the molded seam that would allow liquid or body fluids inside the cover and potentially contaminate the temperature probe. FDA recalls #Z-1396/1398-2010. FDA Enforcement Report, 04/21/10.

PHILIPS HEALTHCARE INC., Seattle, Washington. Defibrillator: 1) Philips Heartstart FRx AED Model 861304, 2) Philips Heartstart (HS1) Onsite AED Model M5066A, 3) Heartstart (HS1) Laerdal AED Model M5067A, 4) Heartstart HS1 Model M5068. Class II. Firm initiated recall ongoing. Firm notified users by telephone and e-mail on November 2, 2009 and by letters on November 9, 2009. Volume in Commerce: 1,856 units. Reason: Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated. FDA recalls #Z-1193/1196-2010. FDA Enforcement Report, 05/12/10.

STRYKER COMMUNICATIONS CORP., Flower Mound, Texas: Manufacturer: Merivaara, Corp., Lahti, Finland. Surgical Table – Vertier. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 13, 2009. Volume in Commerce: 206 units. Reason: In certain positions, product is susceptible to fluid infusions which could possibly result in short circuit or unsolicited movement. FDA recall #Z-1238-2010. FDA Enforcement Report, 05/12/10.