StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
Reason: Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a ...
Z-1956-2013August 21, 2013Louisville, CO
Veridex, LLC
Class IITerminated
CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture an...
Reason: Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification i...
Z-1950-2013August 21, 2013Raritan, NJ
GE Healthcare, LLC
Class IITerminated
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data ta...
Reason: GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa ...
Z-1940-2013August 21, 2013Waukesha, WI
Veridex, LLC
Class IITerminated
CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that captur...
Reason: Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification i...
Z-1949-2013August 21, 2013Raritan, NJ
GE Healthcare, LLC
Class IITerminated
GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); N...
Reason: GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users m...
Z-1944-2013August 21, 2013Waukesha, WI
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DA, SV. Part number: 414567. The product is used with the VITEK 2 automated sy...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1918-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. The product is used with the VITEK 2 automated system...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1920-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. The product is used with the VITEK 2 automated system...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1915-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1909-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 414562. The product is used with the VITEK 2 automated system...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1913-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automa...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1921-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 414566. The product is used with the VITEK 2 automated system...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1917-2013August 14, 2013Hazelwood, MO
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Class IITerminated
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear ...
Reason: Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatm...
Z-1931-2013August 14, 2013HIROSHIMA, N/A
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 NO. Part number: 414565. The product is used with the VITEK 2 automated system...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1916-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563. The product is used with the VITEK 2 automated system...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1914-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DE. Part number: 414539. The product is used with the VITEK 2 automated system...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1910-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 414561. The product is used with the VITEK 2 automated system...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1912-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. Part number: 413861. The product is used with the VITEK 2 automa...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1907-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. The product is used with the VITEK 2 automated system...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1908-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN. Part number: 414560. The product is used with the VITEK 2 automated system...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1911-2013August 14, 2013Hazelwood, MO
Biomerieux Inc
Class IITerminated
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568. The product is used with the VITEK 2 automated sy...
Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from vers...
Z-1919-2013August 14, 2013Hazelwood, MO
Beckman Coulter Inc.
Class IITerminated
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
Reason: The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the...
Z-1834-2013August 7, 2013Brea, CA
Picis Inc.
Class IITerminated
Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in differen...
Reason: Notes associated with prescription are not printed to the prescription or to the patient chart.
Z-1814-2013August 7, 2013Wakefield, MA
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Reason: Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to ...
Z-1848-2013August 7, 2013Malvern, PA
Physio Control, Inc.
Class IITerminated
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG)...
Reason: The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal sh...