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: Possible break in the connector of the Force Sensor.
Z-0096-2018November 22, 2017Warsaw, IN
Beckman Coulter Inc.
Class IITerminated
Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
Reason: Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading process, which should no...
Z-0046-2018November 1, 2017Brea, CA
Edap Technomed Inc.
Class IITerminated
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
Reason: The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining dev...
Z-0049-2018November 1, 2017Austin, TX
Nucletron BV
Class IITerminated
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in t...
Reason: Incorrect source step size may occur in the software plans
Z-0050-2018November 1, 2017Veenendaal, N/A
St Jude Medical Inc.
Class IITerminated
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate progr...
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Z-0032-2018October 25, 2017Sylmar, CA
St Jude Medical Inc.
Class IITerminated
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care S...
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Z-0033-2018October 25, 2017Sylmar, CA
Beckman Coulter Inc.
Class IITerminated
AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
Reason: Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from ...
Z-3135-2017September 27, 2017Brea, CA
Biomerieux Inc
Class IITerminated
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimic...
Reason: Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240...
Z-3134-2017September 27, 2017Hazelwood, MO
Mako Surgical Corporation
Class IITerminated
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation an...
Reason: Software discrepancy of not showing all the EE constants, when the screen is filled.
Z-3131-2017September 20, 2017Davie, FL
Implant Direct Sybron Manufacturing, LLC
Class IITerminated
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant p...
Reason: The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Z-3115-2017September 20, 2017Westlake Village, CA
Zimmer Biomet, Inc.
Class IITerminated
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Ed...
Reason: Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
Z-3117-2017September 20, 2017Warsaw, IN
Mako Surgical Corporation
Class IITerminated
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for o...
Reason: Software discrepancy of not showing all the EE constants, when the screen is filled.
Z-3130-2017September 20, 2017Davie, FL
Merge Healthcare, Inc.
Class IITerminated
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system...
Reason: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Z-3105-2017September 13, 2017Hartland, WI
Beckman Coulter Inc.
Class IITerminated
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to use...
Reason: The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.
Z-3101-2017September 6, 2017Brea, CA
Optovue, Inc.
Class IITerminated
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the r...
Reason: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Z-0009-2018September 6, 2017Fremont, CA
Optovue, Inc.
Class IITerminated
iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measureme...
Reason: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Z-0010-2018September 6, 2017Fremont, CA
Neusoft Medical Systems Co., Ltd.
Class IITerminated
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software vers...
Reason: Software defect
Z-3044-2017September 6, 2017Shenyang, N/A
Biomerieux Inc
Class IITerminated
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
Reason: Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carouse...
Z-3075-2017September 6, 2017Hazelwood, MO
Biomerieux Inc
Class IITerminated
VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testin...
Reason: Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carouse...
Z-3076-2017September 6, 2017Hazelwood, MO
Medspira, Llc
Class IITerminated
mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-00...
Reason: Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.
Z-3072-2017September 6, 2017Minneapolis, MN
Neusoft Medical Systems Co., Ltd.
Class IITerminated
Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X...
Reason: Software defect
Z-3045-2017September 6, 2017Shenyang, N/A
Optovue, Inc.
Class IITerminated
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axi...
Reason: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Z-0008-2018September 6, 2017Fremont, CA
Alcon Research, Ltd.
Class IITerminated
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Reason: Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that resul...
Z-3050-2017August 30, 2017Fort Worth, TX
Alcon Research, Ltd.
Class IITerminated
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Reason: Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that resul...
Z-3049-2017August 30, 2017Fort Worth, TX
Elekta, Inc.
Class IITerminated
iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.