Recall of Device Recall Merge RadSuite software

Recall

76258

Class 2

Z-1180-2017

2015-11-17

2017-02-09

Terminated

United States

2017-02-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152597

The values provided from the pixel value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.

Merge sent an Urgent Medical Device Recall letter dated March 28, 2016 to all affected customers. The letter notifies the customer of the issue and informs them an upgrade is available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 18, 2016. A second letter dated July 11, 2016, was issued asking for a response by August 2, 2016, even though all upgrades were made because the effectiveness checks were not yet completed. The letter and response form contained the same information as the first letter. The recalling firm reported emails were tracked for delivery confirmation and the letters were tracked for delivery by USPS certified services. For further questions, please call 877-744-5369.