Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 8/52015 Class lI: PRODUCT ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 8/52015 Class lI: PRODUCT ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems...Read More

Company: Medtronic MiniMed Inc.. Date of Enforcement Report 8/5/2015 Class lI: PRODUCT MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712. Recall Number Z-2260-2015 REASON Medtronic MiniMed is recalling the MiniMed 620G and...Read More

Company: McKesson Technologies, Inc. Date of Enforcement Report 8/5/2015 Class lI: PRODUCT Paragon Laboratory Management. Recall Number Z-2263-2015 REASON For Paragon Laboratory Management 12.1 and 12.1.1 releases, if used with Microsoft SQL Server 2012, the Final Cumulative Report may incorrectly display the data. RECALLING FIRM/MANUFACTURER McKesson Technologies, Inc., Charlotte, NC on 6/15/2014. Voluntary: Firm Initiated...Read More

Company: Hamilton Medical. Date of Enforcement Report 8/5/2015 Class lI: PRODUCT Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients. Recall Number Z-2057-2015 REASON Customer reports that the ventilator display can freeze. Ventilation continues but...Read More