Z-0372-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2024
- Initiation Date
- September 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118 wireless rechargers
Product Description
Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Brain Stimulation (DBS) system. WR9220A is used with InterStim Micro, Model 97810, as part of Pelvic Health system
Reason for Recall
The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, MD, MI, MN, MO, NC, NJ, OH, PA, SC, TX, VA, and WA. The countries of Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
Code Information
RS6230 - GTIN 00763000564353, Serial numbers: NRA010637N; NRA011389N; NRA013260N; NRA013664N; NRA013924N; NRA014318N; NRA014347N; NRA015823N; NRA015861N; NRA015864N; NRA016334N; NRA016413N; NRA016430N; NRA016432N; NRA016778N; RA017002N; NRA017048N; NRA017227N; NRA017232N; NRA017685N; NRA018697N; NRA018731N; NRA018906N; NRA018936N; NRA018992N; NRA019019N; NRA019026N; NRA019963N; NRA019967N; NRA019968N; NRA019970N; NRA019983N; NRA010657N; NRA012367N; NRA012898N; NRA012915N; NRA013490N; NRA013643N; NRA013877N; NRA013878N; NRA013880N; NRA014248N; NRA014741N; NRA015127N; NRA015142N, NRA010659N; NRA010661N; NRA010663N NRA016424N; NRA016425N; NRA016426N; NRA016431N; RA016433N; NRA021324N. RS7230 - GTIN 00763000540289, Serial numbers: NRA010640N; NRA010650N; NRA010656N: NRA011591N; NRA012896N; NRA012910N; NRA012925N; NRA013884N; NRA010633N; NRA010635N; NRA010641N; NRA010642N; NRA010646N; NRA010652N; NRA010653N; NRA010654N; NRA010655N; NRA010658N; NRA010660N; NRA010664N; NRA010666N; NRA010667N; NRA010668N; NRA010669N; NRA010881N; NRA011216N; NRA011293N; NRA011393N; NRA011713N; NRA011853N; NRA012184N; NRA012897N; NRA012909N; NRA012911N; NRA012912N; NRA012913N; NRA012914N; NRA013502N; NRA013602N; NRA013603N; NRA013634N; NRA013635N; NRA013638N; NRA013639N; NRA013879N; NRA013883N; NRA013899N; NRA013952N; NRA014259N; NRA014944N; NRA015858N; NRA015904N; NRA011189N; NRA011238N; NRA012130N; NRA012185N; NRA012366N; NRA013543N; NRA014132N; NRA014222N; GTIN 0763000827533, Serial numbers: NRA010558N; NRA010627N; NRA015360N; NRA013633N.