Ortho-Clinical Diagnostics, Inc.: VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0

Hazard

During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

Details from the source

Reason for recall: During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system. Distribution: US Nationwide. Global Distribution. Quantity: 216 units Lot/code info: Product Code: 6844461, UDI-DI: 10758750031610; Serial Numbers: J76000050 J76000878 J76001555 J76000033 J76000976 J76000108 J76000905 J76001558 J76000036 J76000983 J76000144 J76000909 J76001559 J76000043 J76001001 J76000148 J76000922 J76001565 J76000045 J76001027 J76000192 J76000930 J76001570 J76000106 J76001035 J76000195 J76000968 J76001577 J76000118 J76001070 J76000199 J76001106 J76001581 J76000211 J76001074 J76000200 J76001171 J76001583 J76000253 J76001095 J76000206 J76001172 J76001589 J76000257 J76001111 J76000207 J76001206 J76001592 J76000265 J76001121 J76000208 J76001207 J76001595 J76000274 J76001130 J76000241 J76001218 J76001596 J76000276 J76001141 J76000298 J76001230 J76001597 J76000278 J76001142 J76000313 J76001231 J76001599 J76000280 J76001144 J76000317 J76001232 J76001600 J76000281 J76001152 J76000324 J76001235 J76001611 J76000284 J76001155 J76000333 J76001239 J76001616 J76000288 J76001159 J76000342 J76001260 J76001617 J76000289 J76001174 J76000352 J76001263 J76001620 J76000290 J76001183 J76000353 J76001274 J76001638 J76000292 J76001189 J76000420 J76001292 J76001639 J76000293 J76001272 J76000422 J76001293 J76001643 J76000318 J76001273 J76000456 J76001294 J76001644 J76000370 J76001285 J76000459 J76001331 J76001647 J76000436 J76001309 J76000460 J76001340 J76001648 J76000446 J76001314 J76000468 J76001351 J76001650 J76000447 J76001328 J76000495 J76001357 J76001652 J76000618 J76001368 J76000502 J76001370 J76001659 J76000620 J76001377 J76000524 J76001376 J76001660 J760006

UPC codes

10758750031610

Source

Official record: FDA (Device enforcement) ↗

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