Z-0050-2025 Class II Ongoing
FDA device recall Z-0050-2025 was initiated by Medtronic Navigation, Inc. on August 22, 2024 and is designated Class II. Reason for recall: Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flip… The recall status is ongoing. Affected quantity: 1,801 systems.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2024
- Initiation Date
- August 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,801 systems
Product Description
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
Reason for Recall
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
Distribution Pattern
Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TN, TX, UT, VA, WA, WI and WV. The countries of Argentina, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, Brazil, BULGARIA, CANADA, CHILE, China, Colombia, Costa Rica, CROATIA, CYPRUS, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, India, ISRAEL, ITALY, Japan, Jordan, KAZAKHSTAN, KENYA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, Malaysia, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, OMAN, PAKISTAN, PANAMA, Philippines, POLAND, PUERTO RICO, QATAR, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, Singapore, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, Turkey, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM.
Code Information
Product Number: 9735762 UDI-DI code: 00763000456986 Serial Numbers: 420002290 N06805776 N07323682 N07323683 N07323687 N07326235 N07334454 N07334475 N07338479 N07338480 N07338482 N07338929 N07354639 N07354642 N07354643 N07354644 N07354645 N07355155 N07357492 N07357493 N07360505 N07360506 N07362322 N07362323 N07364218 N07364220 N07364221 N07365158 N07365160 N07365163 N07365164 N07369302 N07369307 N07401810 N07401811 N07401812 N07401813 N07407569 N07418140 N07418141 N07426193 N07427592 N07427593 N07427597 N07428130 N07428133 N07428134 N07428190 N07428192 N07428193 N07428195 N07428197 N07429001 N07436071 N07436073 N07436074 N07438127 N07438128 N07441426 N07441431 N07448170 N07448371 N07448372 N07449575 N07460062 N07460064 N07461619 N07465933 N07469095 N07469096 N07469097 N07469100 N07469789 N07470357 N07470358 N07471822 N07471823 N07475369 N07475370 N07482977 N07505369 N07508757 N07511354 N07511355 N07511359 N07516935 N07525093 N07525094 N07525099 N07529455 N07533927 N07533928 N07533929 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