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U.S. Department of Health and Human Services

Class 2 Device Recall Scopis ENT Software

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  Class 2 Device Recall Scopis ENT Software see related information
Date Initiated by Firm April 04, 2024
Date Posted May 23, 2024
Recall Status1 Open3, Classified
Recall Number Z-1885-2024
Recall Event ID 94456
510(K)Number K221098  
Product Classification Ear, Nose, and Throat Stereotaxic Instrument - Product Code PGW
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.
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.
Recalling Firm/
Manufacturer		 Stryker Leibinger GmbH & Co. KG
Botzinger Str. 41
Freiburg Im Breisgau Germany
For Additional Information Contact Lacey Marshall
269-270-5950 Ext. 0
Manufacturer 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.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action 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.
Quantity in Commerce 705 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PGW and Original Applicant = Stryker Corporation
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