Day

November 18, 2015
Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis. Recall Number Z-0265-2016 REASON Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA,...
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Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of...
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Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device. Recall Number Z-0259-2016 REASON When performing head or neck scans, the currently displayed SAR...
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Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device. Recall Number Z-0258-2016 REASON When performing head or neck scans, the currently displayed SAR values could be lower...
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Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display...
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Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device. Recall Number Z-0256-2016 REASON When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The...
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Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The Transmit/Receive Body Imaging...
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Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging. Recall Number Z-0254-2016 REASON When performing head or neck scans, the currently displayed...
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http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm468246.htm
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Company: Innokas Medical Oy.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans Recall Number Z-0264-2016 REASON Monitor may shut down unintentionally without restarting. RECALLING FIRM/MANUFACTURER Innokas Medical Oy. Kempele, FI on 10/22/2015. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 756 DISTRIBUTION Nationwide...
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