iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis...
Reason: A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure f...
Z-1893-2018May 23, 2018Brea, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Reason: There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMA...
Z-1745-2018May 23, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
Reason: There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMA...
Reason: Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of...
Z-1643-2018May 16, 2018Brea, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, di...
Reason: Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
Z-1699-2018May 16, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical ima...
Reason: Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
Reason: Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data reconstru...
Z-1597-2018May 9, 2018Hoffman Estates, IL
Radiometer Medical ApS
Class IITerminated
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data wit...
Reason: There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.
Z-1582-2018May 9, 2018Bronshoj, N/A
Roche Diagnostics Corporation
Class IITerminated
Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measur...
Reason: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Z-1611-2018May 9, 2018Indianapolis, IN
Roche Diagnostics Corporation
Class IITerminated
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurem...
Reason: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Z-1613-2018May 9, 2018Indianapolis, IN
Roche Diagnostics Corporation
Class IITerminated
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measure...
Reason: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Z-1612-2018May 9, 2018Indianapolis, IN
Hitachi Ltd., Medical System Operations Group
Class IITerminated
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation tr...
Reason: Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
Z-1585-2018May 9, 2018Kashiwa, N/A
Roche Diagnostics Corporation
Class IITerminated
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurem...
Reason: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Z-1610-2018May 9, 2018Indianapolis, IN
PerkinElmer Life and Analytical Sciences, Wallac, OY
Class IITerminated
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screen...
Reason: Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
Z-1541-2018May 9, 2018Turku, N/A
Heidelberg Engineering
Class IITerminated
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Reason: FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 51...
Z-1535-2018May 2, 2018Franklin, MA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range o...
Reason: Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
Z-1392-2018April 25, 2018Cleveland, OH
Siemens Medical Solutions USA, Inc
Class IITerminated
ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the trea...
Z-1399-2018April 25, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the trea...
Z-1400-2018April 25, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the trea...
Z-1397-2018April 25, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the trea...
Z-1402-2018April 25, 2018Malvern, PA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstructi...
Reason: Surview scan with tube current lower than 30 mA is unable to be initialized.
Z-1396-2018April 25, 2018Cleveland, OH
Siemens Medical Solutions USA, Inc
Class IITerminated
ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the trea...
Z-1401-2018April 25, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the trea...
Reason: Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the...
Z-1362-2018April 18, 2018Brea, CA
Fresenius Medical Care Renal Therapies Group, LLC
Class IITerminated
Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
Reason: The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Vo...