Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-303A Recall Number Z-0018-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...Read More

Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-302A Recall Number Z-0017-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...Read More

Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-301C Recall Number Z-0016-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...Read More

Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-301B Recall Number Z-0015-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...Read More

Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-101A Recall Number Z-0013-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...Read More

Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-101A Recall Number Z-0013-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...Read More

Company:Natus Neurology Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography...Read More