FDAFDA · Food and drugs·Recall number Z-0362-2025
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic images and optical coherence tomography data. The IMAGEnet 6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.
Published November 20, 2024 · Recall initiated: September 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Topcon Medical Systems, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- UDI-DI: 04562123288582 Maestro2 Serial Number AB9071330 AB9070792 AB9071375 AB9071843 AB9072242 AB9070148 AB9072017 AB9071547 AV3071260 AV3071152 AB9071136 AB9070540 AB9072074 AB9071587 AB9072102 AV3070212 AV3070194 AB9071712 AV3071301 AV3070499 AB9072149 AV3071071 AV3071032 AV3071030 AB9070992 AB9071020 AB9070956 AB9072234 AB9072257 AB9071460 AB9071337 AB9070452 AV3070435 AV3070878 AV3070980 AV3071053 AB9070375 AB9071180 AB9070936 AB9071005 AB9070850 AB9071918 AB9071648 AB9071817 AB9071464 AB9071097 AB9070627 AV3070916 AB9070572 AB9070288 AB9070991 AB9070673 AB9071156 AB9070985 AB9071234 AB9071272 AB9070563 AB9071242 AB9071949 AB9072241 AB9071814 AB9072109 AV3070677 AB9070743 AB9070769 AV3070763 AV3070034 AV3070657 AV3070557 AB9070421 AB9070722 AV3070626 AV3070823 AB9070161 AB9070396 AB9070205 AB9071236 AB9071103 AB9070597 AB9072178 AB9072043 AB9071938 AB9071300 AB9070223 AB9072013 AV3070099 AV3070855 AB9070958 AB9070997 AB9070880 AB9071726 AB9071846 AB9072059 AV3070473 AB9071921 AB9070344 AB9072416 AV3070248 AB9071492 AV3070830 AV3071009 AB9070272 AV3070100 AB9070611 AV3070617 AB9071120 AB9071953 AV3070321 AB9071947 AB9070301 AB9070938 AB9072101 AB9072216 AB9070725 AB9072459 AB9070280 AB9071977 AB9071699 AV3071005 AV3070283 AB9070473 AB9070484 AB9072657 AV3070570 AV3071228 AV3071207 AB9071835 AB9071894 AB9071975 AB9071805 AB9071774 AB9070545 AB9070962 AB9071199 AB9071316 AB9071489 AB9072171 AB9071123 AV3070690 AV3070313 AV3071102 AV3070386 AB9071210 AB9071195 AB9070685 AB9071820 AB9071235 AB9072352 AB9070845 AB9072379 AB9072535 AV3070717 AB9072709 AV3070337 AV3071229 AB9070147 AB9070846 AB9070593 AB9071017 AB9072099 AB9072037 AB9071960 AB9072430 AB9070546 AB9071809 AB9072144 AB9071225 AB9070966 AB9071267 AV3070070 AV3071066 AB9071929 AB9072235 AB9071537 AB9071112 AB9070677 AV3071293 AV3070451 AB9072347 AB9070267 AV3070081 AV3071179 AB9071542 AV3070976 AV3071459 AB9072133 AB9072223 AB9071879 AV3070335 AB9072525 AV3070824 AV3071127 AV3071100 AB9070697 AB9072231 AB9072019 AB9071906 AB9071982 AB9071825 AB9070219 AV3070257 AB9070239 AV3070672 AV3071240 AV3071040 AB9072661 AV3070985 AB9071207 AB9070149 AB9072027 AB9071068 AB9071813 AB9072211 AB9071516 AB9070393 AV3070218 AV3070072 AV3071148 AB9071243 AB9072003 AB9071961 AB9072165 AB9072237 AB9070631 AB9071031 AV3070261 AB9071208 AB9070907 AB9072150 AB9071231 AV3070873 AV3070832 AV3071244 AB9071382 AB9071526 AB9070352 AV3070223 AB9071433 AB9070102 AB9071363 AV3070027 AV3071188 AV3070900 AB9071771 AB9071640 AB9070678 AV3070255 AB9071160 AV3070730 AV3070035 AV3070587 AB9071374 AB9071535 AB9070152 AB9071836 AB9071014 AV3070352 AB9070636 AB9072686 AV3070924 AV3070871 AB9070198 AV3070863 AV3070918 AV3071195 AV3070951 AB9071611 AB9070316 AB9070234 AB9071335 AV3070059 AV3070118 AV3070175 AB9071622 AB9072623 AV3070457 AV3070678 AV3070867 AV3070592 AV3070953 AV3070640 AV3070804 AV3070963 AB9071854 AB9070550 AB9071739 AB9071748 AB9071095 AV3070013 AB9071908 AB9070684 AB9071039 AB9072002 AV3070589 AB9070836 AB9070689 AB9070844 AB9071153 AB9070655 AB9071910 AB9070667 AB9071715 AB9070676 AV3070476 AB9070111 AV3070314 AB9072674 AB9070463 AV3070092 AV3070939 AV3070952 AB9071326 AB9070398 AB9071482 AB9071429 AB9071357 AV3070114 AV3070151 AB9070842 AV3070879 AB9071909 AB9071437 AB9072100 AV3070405 AV3070242 AV3070846 AV3070412 AV3070956 AB9071637 AB9071633 AB9071871 AB9071520 AB9071831 AB9071731 AB9070296 AB9071388 AV3070183 AV3070028 AB9072587 AB9071660 AV3070230 AB9072550 AV3070748 AV3070374 AB9070993 AB9070323 AB9071092 AB9071754 AB9071674 AB9070693 AB9071858 AB9071951 AB9072681 AV3070521 AB9072313 AB9072393 AB9071967 AB9070243 AB9071006 AV3070901 AV3070088 AB9072699 AV3070465 AB9071808 AB9071772 AB9072039 AB9071750 AB9070171 AB9070283 AV3070213 AV3070017 AB9071924 AV3070810 AV3070860 AV3070839 AV3070835 AB9070653 AB9070517 AB9071899 AB9071959 AB9071869 AB9071851 AV3070247 AV3070134 AV3070387 AV3070383 AV3070598 AV3070264 AV3070929 AV3070467 AB9071108 AB9072035 AB9072030 AB9071072 AB9072018 AV3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.