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,...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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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...Read More