Baxter Healthcare Corporation: Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph

Hazard

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.

Details from the source

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: 399 units Lot/code info: Software Versions: Software Version V6.0.0 V6.2.3, Release Date 02-Jul-2015; Software Version V7.0.0, Release Date 02-Oct-2017 Units: 1) UDI/DI 00732094262957, Serial Numbers: 118100617841, 118250001722, 118480000511, 119140000676, 119150000331, 119180000544, 119180000545, 119180000546, 119180000547, 119180000548, 119180000549, 119180000550, 119180000551, 119340002011, 119340002012, 119460000996, 119470001912, 120110000469, 120130001657, 120160001284, 120420002132, 120420002133, 120420002134, 120420002135, 120420002136, 121330000576, 121330000577, 121330000578, 121330000579, 121330000580, 121330000581, 121330000582, 121390000797; 2) UDI/DI 00732094263046, Serial Numbers: 118460001965, 119150000243, 119390000178, 119390000179, 119500000539, 120480001168, 9069365, 121030000268, 121130001324, 121270000249, 121380000289, 121480000761, 121480000762, 121480000763, 121480000764, 121480000765, 121480000766, 121480000767, 121480000768, 121480000769, 121480000770, 121480000771, 121490000809, 121490000810, 121490000811, 121370002215, 122020001003, 122020001004, 122020001005, 122020001006, 122020001007, 122020001008, 122020001009, 122020001010, 122020001011, 122020001012, 122020001013, 122050001754, 122050001755, 122050001756, 122050001757, 122050001758, 122050001759, 122040000338, 122040000339, 122040000341, 122050000662, 122050000667, 122120002583, 122120002584, 122120002585, 122120002586, 122120002587, 122120002588, 122120002589, 122120002590, 122120002591, 122120002592, 122120002593,

UPC codes

00732094262957, 118100617841, 118250001722, 118480000511, 119140000676, 119150000331, 119180000544, 119180000545, 119180000546, 119180000547, 119180000548, 119180000549, 119180000550, 119180000551, 119340002011, 119340002012, 119460000996, 119470001912, 120110000469, 120130001657, 120160001284, 120420002132, 120420002133, 120420002134, 120420002135, 120420002136, 121330000576, 121330000577, 121330000578, 121330000579, 121330000580, 121330000581, 121330000582, 121390000797, 00732094263046, 118460001965, 119150000243, 119390000178, 119390000179, 119500000539

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.