Day

March 29, 2017
Company: Zimmer Biomet, Inc.Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery. Recall Number Z-1495-2017 REASON Digital templates were created with the incorrect files. RECALLING FIRM/MANUFACTURER Zimmer Biomet, Inc., Warsaw, IN on 2/14/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME...
Read More
Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT Syngo.plaza, Picture Archiving and Communications System (PACS)Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Recall Number Z-1533-2017 REASON...
Read More
Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT ONCOR” Avant-garde Recall Number Z-1490-2017 REASON Software updates RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 2/14/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 80 systems DISTRIBUTION Nationwide Distribution ___________________________________
Read More
Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT ARTISTE” MV System Recall Number Z-1488-2017 REASON Software updates RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 2/14/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 80 systems DISTRIBUTION Nationwide Distribution ___________________________________
Read More
Company: Siemens Healthcare Diagnostics, IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagents; Incubates reaction vessels; Separates solid and liquid wastes; Measures photon emissions; Performs data reduction; Collects and maintains patient...
Read More
Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT ONCOR” Expression ONCOR” Impression ONCOR” Impression plus Recall Number Z-1491-2017 REASON Software updates RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 2/14/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 80 systems DISTRIBUTION Nationwide Distribution ___________________________________
Read More
Company: Nidek IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser...
Read More
Company: Merge Healthcare, Inc. Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare. Recall Number Z-1498-2017 REASON System locks up which may result in potential patient injury or delay in diagnosis or treatment. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on...
Read More
Company: Merge Healthcare, Inc. Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Merge Cardio software.. Recall Number Z-1486-2017 REASON Cardio study list does not show STAT studies without refreshing. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on 4/4/2016. Voluntary: Firm Initiated recall is ongling. VOLUME OF PRODUCT IN COMMERCE 217 sites potentially have the affected...
Read More
Company: Merge Healthcare, Inc. Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of...
Read More
Company: Merge Healthcare, Inc. Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-1496-2017 REASON For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from...
Read More
Company: Hitachi Medical Systems America Inc Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Hitachi Oasis MRI System Recall Number Z-1540-2017 REASON Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. RECALLING FIRM/MANUFACTURER Hitachi Medical Systems America Inc., Twinsburg, OH on 4/16/2015. Voluntary: Firm Initiated recall...
Read More
Company: Hitachi Medical Systems America Inc Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Hitachi Oasis MRI System Recall Number Z-1542-2017 REASON Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. RECALLING FIRM/MANUFACTURER Hitachi Medical Systems America Inc., Twinsburg, OH on 4/16/2015. Voluntary: Firm Initiated recall...
Read More
Company: Haag-Streit USA IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs). Recall Number Z-1500-2017 REASON There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow. RECALLING FIRM/MANUFACTURER Haag-Streit USA Inc., Mason...
Read More
Company: Stanley Security Solutions Inc. Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button. Recall Number Z-1499-2017...
Read More
Company: CareFusion 303, Inc. Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System. Recall Number Z-1520-2017 REASON Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered...
Read More

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.