ORTHO VISION Analyzer and ORTHO VISION Max Analyzer (2018-05-04)

Starting date:

May 4, 2018

Posting date:

May 25, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66860

• 
  Reason
• 
  Affected products

Affected products

1. ORTHO VISION Analyzer
2. ORTHO VISION Max Analyzer

Reason

Ortho Clinical Diagnostics (Ortho) is issuing this recall to inform customers of a software timing issue that has been detected in ORTHO VISION/VISION Max Analyzer System Software.

The identified anomaly is caused by certain executions within two timing windows in succession. The failure mode is the ORTHO VISION and ORTHO VISION Max Systems do not monitor the door state when a maintenance action is executed. The monitoring of doors while executing maintenance actions is used to determine which devices need to be re-inventoried upon returning to normal - operational mode.

For the failure mode to occur two things have to take place in succession:

• The user has to first achieve timing window a:
  
  when in maintenance mode click on resume processing and as soon as possible after clicking 'yes', go to another tab of the application other than the maintenance tab. If this is performed with the right timing, the machine state will be operational while the "returnmachinecontrolrequested" (the value to indicate that the user wants to transition state maintenance->operational) value will still be effective.
• Once the above scenario occurs then timing window b needs to happen (end state of timing window a is a pre-requisite):
  
  enter maintenance mode and quickly execute a maintenance action before the machine state goes back to operational due to the end state of timing window a. This timing window is very narrow (approximately 1-2 seconds), unless the pipetting device is idle (by recurrentflushsequencerequest) and using 5.10.0 (timing window is expanded in this software version) as the pipette is transitioned out of idle state upon transitioning state maintenance->operational. In the case of the reported anomaly observed in r&d the timing window was approximately 7 seconds.

The end state of timing window b will be that the user can execute maintenance tasks while the instrument will actually be in operational mode, so the door monitoring will be disabled.

To date Ortho has not received customer reports of this behavior occurring.

Affected products