Day

August 3, 2016
Company: Ge Healthcare ItDate of Enforcement Report 8/3/2016 Class lI: PRODUCT Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing...
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Company: Elekta, Inc. Date of Enforcement Report 8/3/2016 Class lI: PRODUCT MOSAIQ Oncology Information System Recall Number Z-2293-2016 REASON It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order. RECALLING FIRM/MANUFACTURER Elekta, Inc., Atlanta,...
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Company: The Metrix Company Date of Enforcement Report 8/3/2016 Class lI: PRODUCT AUTOCOMP6 XPS High Speed Compounder REF 58810 Recall Number Z-2257-2016 REASON An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device,...
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Company: The Metrix Company Date of Enforcement Report 8/3/2016 Class lI: PRODUCT AUTOCOMP6 XP High Speed Compounder REF 58810 Recall Number Z-2258-2016 REASON An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device,...
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Company: The Metrix Company Date of Enforcement Report 8/3/2016 Class lI: PRODUCT AUTOCOMP6 High Speed Compounder Recall Number Z-2259-2016 REASON An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined...
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