VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dime
Check against the official notice below — it lists the full affected range.
Vital Images, Inc. recalled VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), along with their upgrades, and version 6.5. The company discovered through internal testing that certain snapshots taken with these software versions could display with incorrect or reversed image orientation.
A total of 598 units were distributed nationwide across all continental U.S. states plus Washington D.C., as well as internationally to numerous countries including Canada, Australia, and various European and Asian nations. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5.
Reason for recall: Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. Distribution: Nationwide Distribution - all states in continental USA including DC but not OK or RI. OUS: Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Honduras, Hong Kong, Iceland, Ireland, Italy, Korea, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, r Saudi Arabia, Serbia, Singapore, Slovenia, South Africa,Spain , Sweden, Switzerland, Thailand, Tu Quantity: 598 Lot/code info: Serial Number 540819 5040918941 CRB1209125 540837 541722 CRB1107015 541783 CRB1211144 540638 CRB1110030 CRA1107015 541350 5060218759 3070900036 540864 CRU1302045 540935 345221 CRB1206107 CRB1108021 540970 540249 CRB1211148 CRB1105014 CRB1203085 CRB1212173 541173 3070900134 373677 541633 5080115149 540621 541631 541578 542109 5080111321 5090109540 5080109815 541808 CRU1303050 5080105909 5090102074 5060218090 541618 CRU1303046 CRB1211141 CRU1203031 CRU1209037 542118 5080111550 541541 541782 542085 CRB1305211 CRB1203095 540704 541343 540693 CRB1305217 540641 541603 540322 CRB1103012 CRB1111033 CRB1112037 CRB1203084 541902 5060218686 540651 541531 541821 541997 CRB1302196 541672 542009 CRB1201048 540644 540635 CRB1203064 541554 CRB1302179 5050913152 542224 540614 542046 5060220966 540662 CRB1212154 542197 541233 540648 542195 CRB1109023 542163 541659 541590 540487 541131 CRU1212042 542204 5080122943 5090102031 5080115270 540771 CRB1212161 541645 542020 CRB1203094 CRB1302201 3070900386 CRB1203083 541605 CRB1110028 VESADLSV120900 542087 541355 3070900596 2511 542201 5041210039 5041210179 540702 CRU1303049 CRU1303051 CRU1303047 5050311950 CRB1209126 541843 3070900218 CRB1212167 541110 CRU1212043 540795 541519 CRB1201055 CRB1206108 541289 541835 541922 CRB1201050 CRB1209133 541903 50401210047 CRB1206106 CRB1203068 CRU1211040 CRB1203093 CRB1201056 3070900239 541566 540376 540839 5050911699 5080119470 CSV1303001 542082 CRU1107013 541204 541748 CRB1209121 3070900211 542095 541767 CRA130
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.