Company:St. Jude Medical, Inc..Date of Enforcement Report 4/4/2018 Class lI: PRODUCT Proclaim DRG Implantable Pulse Generator, Model Number 3664 Recall Number Z-1170-2018 REASON The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report 4/4/2018 Class lI: PRODUCT 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 unmodified syngo based software options. Recall Number Z-1261-2018 REASON When the...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/4/2018 Class lI: PRODUCT ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL. Recall Number Z-1200-2018 REASON The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions...Read More

Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report 4/4/2018 Class lI: PRODUCT 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: 0735000201006820171130 Recall Number Z-1275-2018 REASON Software issue with Center Beam in Field functionality. Issue can result in incorrect...Read More