8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a n...
FDA Device Recall #Z-1885-2024 — Class II — April 4, 2024
Recall Summary
| Recall Number | Z-1885-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 4, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Leibinger GmbH & Co. KG |
| Location | Freiburg Im Breisgau |
| Product Type | Devices |
| Quantity | 705 units |
Product Description
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 for Recall
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.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
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.
Other Recalls from Stryker Leibinger GmbH & Co. KG
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1785-2024 | Class II | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Inte... | Mar 29, 2024 |
| Z-1234-2023 | Class II | Patient-Fitted Temporomandibular (TMJ) Reconstr... | Dec 6, 2022 |
| Z-0715-2022 | Class II | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog... | Dec 29, 2021 |
| Z-1436-2021 | Class II | DirectInject consists of a sterile dual paste s... | Apr 1, 2021 |
| Z-2902-2018 | Class II | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE ... | Jun 22, 2018 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.