Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 6/10/2020 Class II PRODUCT ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600 Recall Number: Z-2257-2020 REASON Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or...Read More

Company: Hill-Rom, Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT Centrella Smart+ Bed, Catalog Number P7900 Recall Number: Z-2246-2020 REASON The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit. RECALLING FIRM/MANUFACTURER...Read More

Company: Agfa N.V. Date of Enforcement Report: 6/10/2020 Class II PRODUCT AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 – Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations,...Read More

Company: Insulet Corporation Date of Enforcement Report: 6/10/2020 Class II PRODUCT Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG – Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Recall Number: Z-2164-2020 REASON After the device...Read More

Company: Spacelabs Healthcare, Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT Xhibit Central, Model No. 96102 – Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Recall Number: Z-2261-2020 REASON The firm received...Read More

Company: Intuitive Surgical, Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT da Vinci SP surgical system Recall Number: Z-2260-2020 REASON Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only...Read More

Company: Varian Medical Systems, Inc. Date of Enforcement Report: 5/13/2020 Class II PRODUCT Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 – Product Usage: is intended to assist the clinician in the delivery of external beam...Read More

Company: Cuattro LLC Date of Enforcement Report: 5/20/2020 Class II PRODUCT CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 Recall Number: Z-1934-2020 REASON There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient. RECALLING FIRM/MANUFACTURER Cuattro LLC...Read More

Company: The Binding Site Group, Ltd. Date of Enforcement Report: 6/10/2020 Class II PRODUCT The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 – Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on...Read More

Company: Immersivetouch Inc Date of Enforcement Report: 6/10/2020 Class II PRODUCT ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options Recall Number: Z-2041-2020 REASON Observed an internal repetitive software glitch in ImmersiveView. RECALLING FIRM/MANUFACTURER Immersivetouch Inc on 4/3/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation)...Read More

Company: Inpeco S.A. Date of Enforcement Report: 6/10/2020 Class II PRODUCT FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory....Read More

Company: Medtronic Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices. Recall Number: Z-2106-2020 REASON Customers using the firm’s continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12,...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 6/10/2020 Class II PRODUCT System, Tomography Computed Emmission Recall Number: Z-2258-2020 REASON GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic...Read More