Company: Elekta Inc. Date of Enforcement Report: 10/2/2013 Class ll: PRODUCT Monaco RTP System Radiation treatment planning Recall Number Z-2276-2013 REASON Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values. RECALLING FIRM/MANUFACTURER Elekta, Inc, Atlanta, GA on 7/2/2013. Voluntary: Firm Initiated recall is...Read More

Company: Codman & Shurtleff, Inc. Date of Enforcement Report: 10/2/2013 Class l: PRODUCT MedStream Programmable Pump; 20ml – 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 10/2/2013 Class ll: PRODUCT GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T....Read More