Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 12/12/12 Class ll: PRODUCT Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System. Recall Number Z-0465-2013 REASON Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 12/12/12 Class ll: PRODUCT Siemens Mobilette Mira, intended use as Mobile x-ray system. Recall Number Z-0480-2013 REASON There is a risk of lost images during examination. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 10/10.2012. Voluntary: Firm Initiated recall is ongoing. VOLUME OF...Read More

Company: Philips Healthcare Inc. Date of Enforcement Report 12/12/12 Class ll: PRODUCT Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics.Recall Number Z-0475-2013 REASON With Digital Diagnost R2.0.2 a mirrored “R in a circle” is burnt into the image (if mirrored) in the lower right corner...Read More

Company: Natus Medical Incorporated Date of Enforcement Report 12/12/12 Class l: PRODUCT The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant’s head and the body is warmed using radiant warmers. The...Read More