bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 Software update for an instrument which is most commonly...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0322-2013November 28, 2012Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 Software update for the clinical instrument which is most com...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0303-2013November 28, 2012Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621 Software update for the clinical instrument which is...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0316-2013November 28, 2012Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412622 Software update for the clini...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0317-2013November 28, 2012Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical instrument which is most ...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0312-2013November 28, 2012Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Software update for the clinical instrument which is most comm...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0309-2013November 28, 2012Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003 Software update for an instrument which is most commonly used ...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0325-2013November 28, 2012Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical instrument which is mos...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0313-2013November 28, 2012Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 Software update for the clinical instrument which i...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0306-2013November 28, 2012Hazelwood, MO
Mako Surgical Corporation
Class IITerminated
The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to ana...
Reason: MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the...
Z-0385-2013November 28, 2012Plantation, FL
Biomerieux Inc
Class IITerminated
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 Software update for an instrument which is most commo...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0326-2013November 28, 2012Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484 Software update for an instrument which is most commo...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0329-2013November 28, 2012Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002 Software update for an instrument which is most com...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0324-2013November 28, 2012Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software update for an instrument which is most commonly used to...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0327-2013November 28, 2012Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 Software update for the clinical instrument which is...
Reason: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Z-0315-2013November 28, 2012Hazelwood, MO
Sendx Medical Inc
Class IITerminated
ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oxim...
Reason: The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional paramete...
Z-0195-2013November 14, 2012Carlsbad, CA
Sechrist Industries Inc
Class IITerminated
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
Reason: Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the perform...
Z-0208-2013November 14, 2012Anaheim, CA
Philips Medical Systems (Cleveland), Inc.
Class IITerminated
Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide supp...
Reason: Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.
Z-0206-2013November 14, 2012Fitchburg, WI
Sechrist Industries Inc
Class IITerminated
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures
Reason: Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the perform...
Z-0209-2013November 14, 2012Anaheim, CA
Vital Images, Inc.
Class IITerminated
Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6...
Reason: Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects...
Z-0186-2013November 7, 2012Plymouth, MN
Elekta, Inc.
Class IITerminated
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Reason: During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is po...
Z-0118-2013October 31, 2012Norcross, GA
Orthosensor
Class IITerminated
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Ort...
Reason: Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was updated to version 1.82, validated on 02/13/12). Recall was initiated due to customer f...
Z-0122-2013October 31, 2012Sunrise, FL
Beckman Coulter Inc.
Class IITerminated
UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the i...
Reason: Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software instal...
Z-0123-2013October 31, 2012Brea, CA
GE Healthcare, LLC
Class IITerminated
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi...
Reason: GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a...
Z-0125-2013October 31, 2012Waukesha, WI
Beckman Coulter Inc.
Class IITerminated
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base sys...
Reason: The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (prev...