Description of Event or Problem · 0
WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED: (B)(6) (CS) CALLED TO REPORT THAT WHILE PREPPING FOR A TUMOR RESECTION CASE USING THE CRANIAL STEALTH AIR. WHILE UPLOADING MRI SCANS TO THE SYSTEM, THE CS FOUND THAT ALL SCANS WERE REPORTING "NOT OPTIMAL FOR STEALTH." AND WHEN CLICKING ON DETAILS HE FOUND IT REPORTED "MR MODALITY NOT AVAILABLE FOR REGISTRATION". "THIS EXAM IS RESTRICTED FROM USE IN THE TASKS BELOW: AIR" THESE SCANS WERE TO BE MERGED WITH THE CT FROM THE AIR FRAME. TS HAD THE SITE CHECK THEIR IMAGING PROTOCOL AND THE DICOM TAGS. THE SITE WAS USING A SIGNA ARTIST SCANNER. THE SYSTEM WOULD NOT LET THE SITE PROCEED TO REGISTRATION WITH THE CURRENT MRI SCANS. TS ADVISED THE SITE THAT THEY COULD REGISTER OFF OF A CT FIST AND MERGE IN THEIR MRI SCANS. THE SITE TOOK A CT AND THEN WAS SUCCESSFULLY ABLE TO MERGE THEIR SCANS AND PROCEED WITH THE CASE. AUTHOR/DATE/SUBJECT/NOTE: IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).