There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Reason for recall: There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data. Distribution: Worldwide distribution. Quantity: 2461 units Lot/code info: Software Versions: Software Version V6.0.0 V6.3.2, Release Date 02-Jul-2015 Units: 1) UDI/DI 00732094263213, Serial Numbers: 117240573990, 117360584950; 2) UDI/DI 00732094263237, Serial Numbers: 117500600524, 122410000834; 3) UDI/DI 00732094263336, Serial Numbers: 118110620686; 4) UDI/DI 00732094263374, Serial Numbers: 116520545398, 116520545399, 117050553501, 117050553502, 117170565092, 117170565093, 117170565094, 117170565095, 117170565096, 118090616242, 118090616243, 118170632609, 118170632608, 118100617936, 118100617935, 118100617934, 118340000113, 118340000114, 118340000115, 118340000116, 118340000117, 118340000118, 118340000119, 118450001233, 118450001234, 118450001235, 118450001236, 118450001237, 118450001238, 118450001239, 118450001240, 118450001241, 119330000811, 119330000812, 119330000813, 119330000814, 119330000815, 119330000816, 119330000817, 119330000818, 119330000819, 119330000820, 119330000821, 120010000185, 120010000186, 120010000187, 120010000188, 120010000189, 120110000599, 120110000600, 120110000601, 120110000602, 120110000603, 121050000579, 121050000580, 121410001265, 121410001266, 121410001267, 121410001268, 122460001565, 122460001566, 122460001567, 123370000157, 123370000158; 5) UDI/DI 00732094263381, Serial Numbers: 116160400812, 116160400841, 116160400843, 116160400845, 116400529512, 116400529513, 116400530030, 116400530031, 116400530032, 116450536621, 116450536622; 6) UDI/DI 00732094263398, Serial Numbers: 118110620685, 118210639085; 7) UDI/DI 0073209
00732094263213, 117240573990, 117360584950, 00732094263237, 117500600524, 122410000834, 00732094263336, 118110620686, 00732094263374, 116520545398, 116520545399, 117050553501, 117050553502, 117170565092, 117170565093, 117170565094, 117170565095, 117170565096, 118090616242, 118090616243, 118170632609, 118170632608, 118100617936, 118100617935, 118100617934, 118340000113, 118340000114, 118340000115, 118340000116, 118340000117, 118340000118, 118340000119, 118450001233, 118450001234, 118450001235, 118450001236, 118450001237, 118450001238, 118450001239, 118450001240
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.