Company:Beckman Coulter Inc.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100. Recall Number Z-1366-2018 REASON iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria. RECALLING FIRM/MANUFACTURER Beckman...Read More

Company:Beckman Coulter Inc.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer Recall Number Z-1362-2018 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 iQ200 software, but the abnormal...Read More

Company:Philips Electronics North America CorporationDate of Enforcement Report 4/18/2018 Class lI: PRODUCT IntelliVue X3 Patient Monitor.. Recall Number Z-1315-2018 REASON The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to...Read More

Company:Lifeline Systems Company.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator. Recall Number Z-1316-2018 REASON A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable. RECALLING FIRM/MANUFACTURER Lifeline Systems Company, Framingham, MA on 11/13/2017. Voluntary: Firm Initiated recall...Read More

Company:Fresenius Medical Care Renal Therapies Group, LLCDate of Enforcement Report 4/18/2018 Class lI: PRODUCT Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis. Recall Number Z-1365-2018 REASON The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result...Read More

Company:Beckman Coulter Inc.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland. Recall Number Z-1341-2018 REASON The device may process...Read More