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November 11, 2015
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Company: Otto Bock Healthcare GmbHG Date of Enforcement Report 11/11/2015 Class lI: PRODUCT iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66* Triton Smart Ankle. Recall Number Z-0209-2016 REASON Otto Bock Healthcare GmbH has identified a software issue where the foot can produce an undesired response (can move into dorsiflexion)...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 11/11/2015 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A Recall Number Z-0204-2016 REASON 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report 11/11/2015 Class lI: PRODUCT VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro quantitative measurement of a variety of analytes...
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Company: GE Healthcare.Date of Enforcement Report 11/11/2015 Class lI: PRODUCT The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this...
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Company: GE Healthcare.Date of Enforcement Report 11/11/2015 Class lI: PRODUCT The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system...
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Company: Brainlab AG Date of Enforcement Report 11/11/2015 Class lI: PRODUCT Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It...
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Company: Steris Corporation Date of Enforcement Report 11/11/2015 Class lI: PRODUCT AMSCO 400 and AMSCO C Small Steam Sterilizers Recall Number Z-0210-2016 REASON In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 11/11/2015 Class lI: PRODUCT HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the...
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