Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures a...
Reason: OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital ...
Z-0258-2018January 17, 2018Scottsdale, AZ
Orthoscan, Inc.
Class IITerminated
Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures a...
Reason: OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital ...
Z-0259-2018January 17, 2018Scottsdale, AZ
Orthoscan, Inc.
Class IITerminated
Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures...
Reason: OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital ...
Z-0261-2018January 17, 2018Scottsdale, AZ
Orthoscan, Inc.
Class IITerminated
Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures a...
Reason: OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital ...
Z-0260-2018January 17, 2018Scottsdale, AZ
Smiths Medical ASD Inc.
Class IITerminated
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration ...
Reason: Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate...
Z-0314-2018January 10, 2018Minneapolis, MN
Smiths Medical ASD Inc.
Class IITerminated
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of...
Reason: Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate...
Z-0313-2018January 10, 2018Minneapolis, MN
Smiths Medical ASD Inc.
Class IITerminated
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Reason: Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match t...
Z-0307-2018January 10, 2018Minneapolis, MN
Implant Direct Sybron Manufacturing, LLC
Class IITerminated
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to creat...
Reason: The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians...
Z-0283-2018December 27, 2017Westlake Village, CA
Normand Informatique
Class IITerminated
Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connecte...
Reason: Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.
Z-0235-2018December 20, 2017Arras CEDEX, N/A
Ortho-Clinical Diagnostics
Class IITerminated
enGen Track System with TCAutomation Software Version 4.2
Reason: A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reint...
Z-0254-2018December 20, 2017Rochester, NY
Roche Diabetes Care, Inc.
Class IITerminated
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Man...
Reason: Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter th...
Z-0197-2018December 13, 2017Indianapolis, IN
GE Medical Systems Information Technologies, Inc.
Class IITerminated
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic ...
Reason: Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Z-0202-2018December 13, 2017Milwaukee, WI
Zimmer Biomet, Inc.
Class IITerminated
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instr...
Reason: The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
Z-0184-2018December 6, 2017Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeon...
Reason: A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.
Z-0177-2018December 6, 2017Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative ...
Reason: Software corrections reactivating the cooperative endoscopy mode.
Z-0161-2018November 29, 2017Warsaw, IN
Spacelabs Healthcare, Ltd.
Class ITerminated
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environme...
Reason: Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display ...
Z-0072-2018November 29, 2017Hertford, N/A
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, commu...
Reason: Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving fr...
Z-0168-2018November 29, 2017Malvern, PA
Zimmer Biomet, Inc.
Class IITerminated
ROSA Surgical Device 2.5.8
Reason: Potential for software to change the final tool orientation for the command position without command.
Z-0115-2018November 29, 2017Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instrume...
Reason: Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
Z-0167-2018November 29, 2017Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
Reason: An undetected shift between the information displayed in the navigation software and the actual patient anatomy
Z-0102-2018November 22, 2017Warsaw, IN
Siemens Medical Solutions USA, Inc.
Class IITerminated
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole...
Reason: The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad...
Z-0093-2018November 22, 2017Hoffman Estates, IL
Beckman Coulter Inc.
Class IITerminated
AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic d...
Reason: The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
Z-0091-2018November 22, 2017Brea, CA
Zimmer Biomet, Inc.
Class IITerminated
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an inst...
Reason: Observed instability of the device.
Z-0099-2018November 22, 2017Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instr...
Reason: Potential failure of the optical distance sensor due to cable disconnection.
Z-0100-2018November 22, 2017Warsaw, IN
Siemens Medical Solutions USA, Inc.
Class IITerminated
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole ...
Reason: The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad...