Recall archive / FDA device enforcement

8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solut... — FDA record Z-1885-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 4, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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 natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.
Reason: 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.
Classification: Class II
Recalling firm: Stryker Leibinger GmbH & Co. KG
Quantity: 705 units
Agency-reported status: Ongoing
Source record identifier: Z-1885-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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.

Label field

Details supplied by the agency

Lot, code or applicability

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.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: May 29, 2024
Recall initiation date: Apr 4, 2024
Center classification date: May 23, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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