Syngo.via. Medical Device Software. Picture archiving and communications system.
Reason: A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instea...
Z-1303-2018April 11, 2018Malvern, PA
Phadia Ab
Class IITerminated
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version...
Reason: We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecti...
Z-1276-2018April 11, 2018Uppsala, N/A
Invivo Corporation
Class IITerminated
DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for othe...
Reason: Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client. The defect causes the pharmacokinetic (...
Z-1289-2018April 11, 2018Gainesville, FL
Fresenius Medical Care Renal Therapies Group, LLC
Class IITerminated
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861...
Reason: When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialy...
Z-1278-2018April 11, 2018Waltham, MA
Baxter Healthcare Corporation
Class IITerminated
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute rena...
Reason: Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additi...
Z-1280-2018April 11, 2018Deerfield, IL
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmod...
Reason: When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning ...
Z-1261-2018April 4, 2018Malvern, PA
RAYSEARCH LABORATORIES AB
Class IITerminated
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 073500020100682017...
Reason: Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
Z-1275-2018April 4, 2018Stockholm
Stryker Instruments Div. of Stryker Corporation
Class IITerminated
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of but...
Reason: Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker¿ N...
Z-1216-2018April 4, 2018Portage, MI
Philips Electronics North America Corporation
Class IIITerminated
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in ...
Reason: Update XL¿ device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of informatio...
Z-0978-2018March 21, 2018Andover, MA
Mindray DS USA, Inc. dba Mindray North America
Class IITerminated
A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently...
Reason: A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
Z-0847-2018March 14, 2018Mahwah, NJ
Philips Medical Systems (Cleveland) Inc
Class IITerminated
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Reason: 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or...
Z-0841-2018March 14, 2018Cleveland, OH
Mindray DS USA, Inc. dba Mindray North America
Class IITerminated
A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, con...
Reason: A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
Z-0846-2018March 14, 2018Mahwah, NJ
Medtronic Navigation, Inc.-Littleton
Class IITerminated
O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS ...
Reason: Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image recon...
Z-0928-2018March 14, 2018Littleton, MA
Abbott Point Of Care Inc.
Class IITerminated
i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
Reason: Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action Ranges, and Custom ...
Z-0926-2018March 14, 2018Princeton, NJ
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer re...
Reason: Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for ...
Z-0839-2018March 14, 2018Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer rec...
Reason: Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for ...
Z-0840-2018March 14, 2018Cleveland, OH
Fresenius Medical Care Renal Therapies Group, LLC
Class IITerminated
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Reason: While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate ...
Z-0829-2018March 7, 2018Waltham, MA
ZOLL Medical Corporation
Class IITerminated
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or...
Reason: A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
Z-0812-2018March 7, 2018Chelmsford, MA
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.via systems with SW VB20A
Reason: A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs...
Z-0808-2018March 7, 2018Malvern, PA
Steris Corporation
Class IITerminated
V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
Reason: Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
Z-0772-2018March 7, 2018Mentor, OH
Philips Electronics North America Corporation
Class IITerminated
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 ...
Reason: Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Any subsequent attempt to per...
Z-0776-2018March 7, 2018Andover, MA
Philips Electronics North America Corporation
Class IITerminated
Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or...
Reason: Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consen...
Z-0684-2018February 28, 2018Andover, MA
Fujifilm Medical Systems U.S.A., Inc.
Class IITerminated
Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography syste...
Reason: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and ...
Z-0659-2018February 28, 2018Stamford, CT
Roche Diagnostics Corporation
Class IITerminated
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Reason: A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
Z-0675-2018February 28, 2018Indianapolis, IN
Medtronic Inc.
Class IITerminated
Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro...
Reason: Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result in incorrect reports...