CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8...
Reason: The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO...
Z-0033-2013October 17, 2012Brea, CA
Beckman Coulter Inc.
Class IITerminated
TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and C...
Reason: The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO...
Z-0035-2013October 17, 2012Brea, CA
Beckman Coulter Inc.
Class IITerminated
CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD...
Reason: The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO...
Z-0034-2013October 17, 2012Brea, CA
Imaging Sciences International, LLC
Class IITerminated
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Reason: A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients wit...
Z-2463-2012October 3, 2012Hatfield, PA
Hologic, Inc.
Class IITerminated
Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic v...
Reason: InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be li...
Z-2452-2012October 3, 2012Bedford, MA
RAYSEARCH LABORATORIES AB
Class IITerminated
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a ...
Reason: This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incid...
Z-2444-2012October 3, 2012Stockholm, N/A
Hologic, Inc.
Class IITerminated
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic...
Reason: Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM i...
Z-2453-2012October 3, 2012Bedford, MA
ZOLL Medical Corporation
Class IITerminated
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other card...
Reason: Shipped with incorrect software
Z-2401-2012September 26, 2012Chelmsford, MA
RAYSEARCH LABORATORIES AB
Class IITerminated
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To determine if the version you are using is affected, bring up the About box in the SharePlan application...
Reason: This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None ...
Z-2378-2012September 26, 2012Stockholm
Philips Medical Systems (Cleveland) Inc
Class IIITerminated
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x...
Reason: Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the ...
Z-2404-2012September 26, 2012Cleveland, OH
Haag-Streit USA Inc
Class IITerminated
Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points ...
Reason: The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.
Z-2411-2012September 26, 2012Mason, OH
BD Biosciences, Systems & Reagents
Class IITerminated
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD ...
Reason: Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
Z-2397-2012September 26, 2012San Jose, CA
Roche Molecular Systems, Inc.
Class IITerminated
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
Reason: When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to ...
Z-2403-2012September 26, 2012Branchburg, NJ
GE Healthcare, LLC
Class IITerminated
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Reason: Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, al...
Z-2255-2012September 19, 2012Waukesha, WI
Sunquest Information Systems, Inc.
Class IITerminated
Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extens...
Reason: Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is used and the "Event m...
Z-2332-2012September 19, 2012Tucson, AZ
Volcano Corporation
Class IITerminated
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and dist...
Reason: The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itse...
Z-2345-2012September 19, 2012Rancho Cordova, CA
GE Healthcare, LLC
Class IITerminated
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoro...
Reason: GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with ...
Z-2376-2012September 19, 2012Waukesha, WI
GE Healthcare, LLC
Class IITerminated
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Reason: Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, al...
Z-2256-2012September 19, 2012Waukesha, WI
Trek Diagnostic Systems
Class IIITerminated
VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer ...
Reason: Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling ...
Z-2323-2012September 12, 2012Cleveland, OH
RAYSEARCH LABORATORIES AB
Class IITerminated
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system desi...
Reason: The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incid...
Z-2324-2012September 12, 2012Stockholm, N/A
Capintec Inc
Class IITerminated
Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement...
Reason: Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake p...
Z-2312-2012September 12, 2012Pittsburgh, PA
Mindray DS USA, Inc. d.b.a. Mindray North America
Class IITerminated
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indic...
Reason: Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies...
Z-2279-2012September 5, 2012Mahwah, NJ
Cisco Systems Inc
Class IITerminated
Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is int...
Reason: Software anomaly may result in incorrect values and interpretations. The initial vital signs reading will display accurately on the Cisco Health Presence Vitals tab and the OnePlac...
Z-2263-2012September 5, 2012San Jose, CA
Sendx Medical Inc
Class IITerminated
ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (wi...
Reason: The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.
Z-2304-2012September 5, 2012Carlsbad, CA
Beckman Coulter Inc.
Class IITerminated
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System ...
Reason: The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause err...