Scopis ENT Software (Stryker) – Visual Feedback Misalignment (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the nat
Brand
Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany
Lot Codes / Batch Numbers
Sofware Version: NOVA 3.6.0 RC16, Product Code: 8000-021-002, UDI/DI: 07613327514179, Serial Numbers: 10984, 10110, 10164, 10454, 10762, 10387, 10120, 10252, 10414, 10612, 10408, 10673, 11013, 11032, 10566, 10974, 0310-B, 10326, 10442, 10729, 10681, 10552, 10088, 10476, 10307, 10121, 10371, 0252-B, 10262, 10602, 10613, 10381, 10234, 200774, 10135, 0304-B, 10303, 10257, 10639, 10445, 10684, 10740, 10986, 10413, 10079, 10528, 10565, 10482, 10209, 10574, 10606, 10229, 10214, 10797, 0335-B, 10284, 10465, 10295, 10308, 0282-B, 83B750AD, 0287-B, 10763, 10434, 11025, 10578, 10473, 10596, 0291-B, 10624, 10591, 11092, 10758, 10097, 10294, 0251-B, 10597, 10769, 0309-B, 10765, 0313-B, 0281-B, 10513, 11088, 10057, 10337, 10464, 10621, 10699, 10509, 10421, 10549, 10003, 10499, 10661, 10668, 0292-B, 10416, 0263-B, 10654, 10571, 0329-B, 10934, 10798, 11022, 10610, 10766, 10471, 10437, 10648, 10410, 10403, 10159, 10192, 10372, 10189, 10193, 10642, 10390, 10771, 10202, 10806, 10237, 10296, 0244-B, 0307-B, 10034, 10440, 10704, 10101, 10153, 10098, 10388, 10720, 10943, 10944, 10994, 10695, 10608, 10615, 10054, 10076, 10015, 10089, 10208, 10776, 10780, 11111, 10586, 10759, 10431, 10772, 10376, 10563, 10978, 10989, 10369, 10641, 10796, 10558, 10660, 10071, 10987, 10953, 10982, 10744, 10026, 0325-B, 10959, 11000, 10453, 0332-B, 10055, 10335, 10742, 10649, 10983, 10512, 10958, 10268, 10640, 0280-B, 11075, 11117, 10356, 10429, 10432, 10659, 10677, 10319, 10311, 10332, 10757, 10809, 10523, 10382, 10451, 10495, 10997, 11116, 11018, 10083, 10672, 10775, 10053, 10195, 10330, 10161, 10007, 10328, 10949, 11031, 10781, 10990, 10350, 10750, 10191, 10033, 10056, 10446, 10078, 10516, 10373, 10722, 10136, 10210, 10091, 10255, 10253, 10060, 10427, 10162, 10297, 10731, 10935, 0285-B, 10336, 10760, 10386, 10347, 10286, 10165, 10041, 10456, 10312, 10417, 10500, 10133, 10224, 10031, 10040, 10100, 10784, 10248, 10423, 10215, 10951, 10092, 0260-B, 10185, 10127, 10112, 10790, 10299, 10316, 10435, 10459, 10075, 10479, 10357, 10627, 10732, 10734, 0343-B, 0320-B, 10517, 10455, 10590, 11030, 10383, 10043, 10096, 10789, 10631, 10489, 10791, 10220, 10658, 10348, 10143, 10114, 10625, 10799, 11108, 10103, 10522, 10126, 10066, 10980, 11102, 0318-B, 11005, 10177, 10662, 10166, 10197, 10300, 10406, 10181, 0326-B, 10443, 10331, 10364, 10368, 10592, 10062, 10366, 10349, 10353, 11097, 10155, 10218, 10227, 10230, 10315, 10618, 10021, 10787, 11038, 0271-B, 10365, 10637, 10141, 10525, 10341, 10433, 10696, 0333-B, 10401, 10633, 10211, 10231, 10052, 10794, 10685, 10157, 10213, 10081, 10123, 10090, 10199, 10678, 11020, 10216, 10377, 10424, 10212, 10361, 10059, 10109, 10736, 10344, 10693, 10977, 11004, 10016, 10168, 10171, 10691, 10006, 10458, 10324, 10156, 10190, 10221, 10363, 10475, 0322-B, 0339-B, 10692, 10679, 10082, 10573, 10603, 10267, 10541, 10999, 10169, 10628, 10576, 10345, 10738, 10354, 10238, 0259-B, 10077, 0306-B, 10461, 10172, 10243, 10233, 10327, 0327-B, 11023, 11114, 10450, 10398, 10404, 0303-B, 10400, 10412, 10593, 10072, 10514, 10239, 10069, 10244, 10249, 10761, 10359, 10739, 10352, 10163, 10374, 10698, 10342, 10607, 10635, 10058, 10425, 10419, 10950, 10405, 10422, 10223, 0308-B, 10010, 10594, 10205, 10370, 10474, 10247, 10020, 10174, 10184, 10188, 10128, 11003, 10689, 10701, 10795, 10074, 10266, 10288, 10008, 10203, 10966, 10438, 10955, 10073, 10080, 10333, 10777, 10508, 10325, 10086, 10104, 10469, 10755, 10810, 10671, 10152, 10393, 10657, 10105, 10298, 10524, 10805, 10375, 10402, 10094, 10358, 10498, 10501, 10384, 10391, 10993, 10064, 10175, 10397, 10560, 10570, 10630, 10132, 10579, 10439, 10415, 10306, 10343, 10477, 10323, 10737, 10589, 10304, 10338, 10460, 10598, 10779, 10988, 10346, 11082, 10436, 10362, 10334, 10682, 10653, 10583, 10724, 10725, 10407, 10380, 10409, 10595, 10137, 10656, 10389, 10611, 10638, 11036, 11037, 10577, 10609, 10587, 10626, 10965, 11017, 11112, 10547, 10954, 11029, 11026, 10979, 10985, 11080, 10981, 11099, 10207, 10049, 10580, 10144, 10723.
Products Sold
Sofware Version: NOVA 3.6.0 RC16, Product Code: 8000-021-002; UDI/DI: 07613327514179; Serial Numbers: 10984, 10110, 10164, 10454, 10762, 10387, 10120, 10252, 10414, 10612, 10408, 10673, 11013, 11032, 10566, 10974, 0310-B, 10326, 10442, 10729, 10681, 10552, 10088, 10476, 10307, 10121, 10371, 0252-B, 10262, 10602, 10613, 10381, 10234, 200774, 10135, 0304-B, 10303, 10257, 10639, 10445, 10684, 10740, 10986, 10413, 10079, 10528, 10565, 10482, 10209, 10574, 10606, 10229, 10214, 10797, 0335-B, 10284, 10465, 10295, 10308, 0282-B, 83B750AD, 0287-B, 10763, 10434, 11025, 10578, 10473, 10596, 0291-B, 10624, 10591, 11092, 10758, 10097, 10294, 0251-B, 10597, 10769, 0309-B, 10765, 0313-B, 0281-B, 10513, 11088, 10057, 10337, 10464, 10621, 10699, 10509, 10421, 10549, 10003, 10499, 10661, 10668, 0292-B, 10416, 0263-B, 10654, 10571, 0329-B, 10934, 10798, 11022, 10610, 10766, 10471, 10437, 10648, 10410, 10403, 10159, 10192, 10372, 10189, 10193, 10642, 10390, 10771, 10202, 10806, 10237, 10296, 0244-B, 0307-B, 10034, 10440, 10704, 10101, 10153, 10098, 10388, 10720, 10943, 10944, 10994, 10695, 10608, 10615, 10054, 10076, 10015, 10089, 10208, 10776, 10780, 11111, 10586, 10759, 10431, 10772, 10376, 10563, 10978, 10989, 10369, 10641, 10796, 10558, 10660, 10071, 10987, 10953, 10982, 10744, 10026, 0325-B, 10959, 11000, 10453, 0332-B, 10055, 10335, 10742, 10649, 10983, 10512, 10958, 10268, 10640, 0280-B, 11075, 11117, 10356, 10429, 10432, 10659, 10677, 10319, 10311, 10332, 10757, 10809, 10523, 10382, 10451, 10495, 10997, 11116, 11018, 10083, 10672, 10775, 10053, 10195, 10330, 10161, 10007, 10328, 10949, 11031, 10781, 10990, 10350, 10750, 10191, 10033, 10056, 10446, 10078, 10516, 10373, 10722, 10136, 10210, 10091, 10255, 10253, 10060, 10427, 10162, 10297, 10731, 10935, 0285-B, 10336, 10760, 10386, 10347, 10286, 10165, 10041, 10456, 10312, 10417, 10500, 10133, 10224, 10031, 10040, 10100, 10784, 10248, 10423, 10215, 10951, 10092, 0260-B, 10185, 10127, 10112, 10790, 10299, 10316, 10435, 10459, 10075, 10479, 10357, 10627, 10732, 10734, 0343-B, 0320-B, 10517, 10455, 10590, 11030, 10383, 10043, 10096, 10789, 10631, 10489, 10791, 10220, 10658, 10348, 10143, 10114, 10625, 10799, 11108, 10103, 10522, 10126, 10066, 10980, 11102, 0318-B, 11005, 10177, 10662, 10166, 10197, 10300, 10406, 10181, 0326-B, 10443, 10331, 10364, 10368, 10592, 10062, 10366, 10349, 10353, 11097, 10155, 10218, 10227, 10230, 10315, 10618, 10021, 10787, 11038, 0271-B, 10365, 10637, 10141, 10525, 10341, 10433, 10696, 0333-B, 10401, 10633, 10211, 10231, 10052, 10794, 10685, 10157, 10213, 10081, 10123, 10090, 10199, 10678, 11020, 10216, 10377, 10424, 10212, 10361, 10059, 10109, 10736, 10344, 10693, 10977, 11004, 10016, 10168, 10171, 10691, 10006, 10458, 10324, 10156, 10190, 10221, 10363, 10475, 0322-B, 0339-B, 10692, 10679, 10082, 10573, 10603, 10267, 10541, 10999, 10169, 10628, 10576, 10345, 10738, 10354, 10238, 0259-B, 10077, 0306-B, 10461, 10172, 10243, 10233, 10327, 0327-B, 11023, 11114, 10450, 10398, 10404, 0303-B, 10400, 10412, 10593, 10072, 10514, 10239, 10069, 10244, 10249, 10761, 10359, 10739, 10352, 10163, 10374, 10698, 10342, 10607, 10635, 10058, 10425, 10419, 10950, 10405, 10422, 10223, 0308-B, 10010, 10594, 10205, 10370, 10474, 10247, 10020, 10174, 10184, 10188, 10128, 11003, 10689, 10701, 10795, 10074, 10266, 10288, 10008, 10203, 10966, 10438, 10955, 10073, 10080, 10333, 10777, 10508, 10325, 10086, 10104, 10469, 10755, 10810, 10671, 10152, 10393, 10657, 10105, 10298, 10524, 10805, 10375, 10402, 10094, 10358, 10498, 10501, 10384, 10391, 10993, 10064, 10175, 10397, 10560, 10570, 10630, 10132, 10579, 10439, 10415, 10306, 10343, 10477, 10323, 10737, 10589, 10304, 10338, 10460, 10598, 10779, 10988, 10346, 11082, 10436, 10362, 10334, 10682, 10653, 10583, 10724, 10725, 10407, 10380, 10409, 10595, 10137, 10656, 10389, 10611, 10638, 11036, 11037, 10577, 10609, 10587, 10626, 10965, 11017, 11112, 10547, 10954, 11029, 11026, 10979, 10985, 11080, 10981, 11099, 10207, 10049, 10580, 10144, 10723.
Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany is recalling 8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-g due to Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical re. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.
Recommended Action
Per FDA guidance
On April 22, 2024 an URGENT MEDICAL DEVICE FIELD ACTION letters were sent to customers. Next Steps: 1. Locate any ENU. Quarantine and discontinue use until software on device has been confirmed. - Locate software version and serial number (see pg. 2 for instructions). - Your Stryker Sales Representatives may help, if needed. 2. Return the enclosed Business Reply Form (BRF) via email to instruments.recalls@stryker.com. - If Scopis ENT Software with TGS version NOVA 3.6.0 RC16 is installed, Stryker will arrange shipment of compliant software. 3. Once compliant software is received and installed, return the enclosed Software Update Form via email to instruments.recalls@stryker.com to confirm completion of the recall action steps. 4. Maintain this notification internally until all required actions have been completed. Please contact Lacey Marshall at 269-270-5950 or Instruments.recalls@stryker.com with questions or concerns. Report any serious adverse events or product quality problems to Stryker Instruments: 1-800-253-3210. Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, or by fax or phone. Online: ww.fda.gov/Safety/MedWatch/HowToReport/default.htm Fax: (800) FDA-0178 Phone: (800) FDA-1088.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026