Stryker Leibinger GmbH & Co. KG: 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 sur

Hazard

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.

Details from the source

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: US Nationwide distribution. Quantity: 705 units Lot/code info: 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, 104

UPC codes

07613327514179

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.