FDAFDA · Food and drugs·Recall number Z-0663-2020
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Published December 18, 2019 · Recall initiated: November 16, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- LivaNova USA Inc
- Distributor
- IL, AK, AL, AR, AZ, CA, CA , CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD MI, MN, MO, MS, MT, NC, ND, NE, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WA , WI, WV, WY,
- Lot
- Serial Number / UDI# GWQ57F2 01054250257504811118060521GWQ57F29910-0011-0500 72S77F2 0105425025750481111806052172S77F29910-0011-0500 1ZFTKJ2 010542502575048111180604211ZFTKJ29910-0011-0500 BRQ57F2 01054250257504811118053121BRQ57F29910-0011-0500 9CP57F2 010542502575048111180529219CP57F29910-0011-0500 HCR77F2 01054250257504811118050421HCR77F29910-0011-0500 H5P57F2 01054250257504811118050321H5P57F29910-0011-0500 19S77F2 0105425025750481111804172119S77F29910-0011-0500 3YFTKJ2 010542502575048111180405213YFTKJ29910-0011-0500 68Q57F2 0105425025750481111803302168Q57F29910-0011-0500 H4S77F2 01054250257504811118031521H4S77F29910-0011-0500 C7KRPJ2 01054250257504811118031521C7KRPJ29910-0011-0500 8WQ77F2 010542502575048111180315218WQ77F29910-0011-0500 1VQ77F2 010542502575048111180315211VQ77F29910-0011-0500 1LJRPJ2 010542502575048111180315211LJRPJ29910-0011-0500 JFJRPJ2 01054250257504811118031421JFJRPJ29910-0011-0500 HVP57F2 01054250257504811118031421HVP57F29910-0011-0500 CBJRPJ2 01054250257504811118031421CBJRPJ29910-0011-0500 9HJRPJ2 010542502575048111180314219HJRPJ29910-0011-0500 1LQ57F2 010542502575048111180313211LQ57F29910-0011-0500 B6S77F2 01054250257504811118030921B6S77F29910-0011-0500 5NT77F2 010542502575048111180309215NT77F29910-0011-0500 75P57F2 0105425025750481111803052175P57F29910-0011-0500 32S77F2 0105425025750481111803052132S77F29910-0011-0500 6P7G1F2 010542502575048111180302216P7G1F29910-0011-0500 1J0C7F2 010542502575048111180228211J0C7F29910-0011-0500 J4R57F2 01054250257504811118022721J4R57F29910-0011-0500 61R77F2 0105425025750481111802272161R77F29910-0011-0500 1C0C7F2 010542502575048111180227211C0C7F29910-0011-0500 1LYB7F2 010542502575048111180226211LYB7F29910-0011-0500 DPS77F2 01054250257504811118021521dps77f29910-0011-0500 9LQ57F2 010542502575048111180215219lq57f29910-0011-0500 HDR77F2 01054250257504811118021421HDR77F29910-0011-0500 B5S77F2 01054250257504811118021421B5S77F29910-0011-0500 HCJRPJ2 01054250257504811118020721HCJRPJ29910-0011-0500 CCT77F2 01054250257504811118020721CCT77F29910-0011-0500 6BR77F2 010542502575048111180207216BR77F29910-0011-0500 4GR77F2 010542502575048111180207214GR77F29910-0011-0500 HDQ57F2 01054250257504811118020621HDQ57F29910-0011-0500 HBKRPJ2 01054250257504811118020621HBKRPJ29910-0011-0500 D9T77F2 01054250257504811118020621D9T77F29910-0011-0500 56JRPJ2 0105425025750481111802062156JRPJ29910-0011-0500 4CR77F2 010542502575048111180206214CR77F29910-0011-0500 2FT77F2 010542502575048111180206212FT77F29910-0011-0500 HWJRPJ2 01054250257504811118020521HWJRPJ29910-0011-0500 9LJRPJ2 010542502575048111180205219LJRPJ29910-0011-0500 F9T0QJ2 01054250257504811118020221F9T0QJ29910-0011-0500 BSZ1QJ2 01054250257504811118020221BSZ1QJ29910-0011-0500 JCJRPJ2 01054250257504811118020121JCJRPJ29910-0011-0500 BXJRPJ2 01054250257504811118020121BXJRPJ29910-0011-0500 B2Q57F2 01054250257504811118020121B2Q57F29910-0011-0500 9BKRPJ2 010542502575048111180201219BKRPJ29910-0011-0500 7GT77F2 010542502575048111180201217GT77F29910-0011-0500 8JJRPJ2 010542502575048111180131218JJRPJ29910-0011-0500 3QJRPJ2 010542502575048111180131213QJRPJ29910-0011-0500 FNT7QJ2 01054250257504811118011821FNT7QJ29910-0011-0500 CNT7QJ2 01054250257504811118011821CNT7QJ29910-0011-0500 77KRPJ2 0105425025750481111801182177KRPJ29910-0011-0500 1VZ1QJ2 010542502575048111180118211VZ1QJ29910-0011-0500 1QJRPJ2 010542502575048111180118211QJRPJ29910-0011-0500 19T0QJ2 0105425025750481111801182119T0QJ29910-0011-0500 5CD820D5WV 010542502575042911180920215CD820D5WV9910-0011-8701 5CD8212Q6W 010542502575042911180919215CD8212Q6W9910-0011-8701 5CD8212Q6M 010542502575042911180919215CD8212Q6M9910-0011-8701 5CD8212Q57 010542502575042911180919215CD8212Q579910-0011-8701 5CD8212Q55 010542502575042911180919215CD8212Q559910-0011-8701 5CD8212Q51 010542502575042911180919215CD8212Q519910-0011-8701 5CD8212Q44 010542502575042911180919215CD8212Q449910-0011-8701 5CD8212Q1R 010542502575042911180919215CD8212Q1R9910-0011-870
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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