Advanced Bionics LLC: S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.

Recall number

Z-0958-2009

Recalling firm

Advanced Bionics LLC

Product

S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.

Status

Terminated

Initiated

2008-07-24

Posted

2009-02-03

Terminated

2012-03-23

Reason

Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but can

Root cause

Employee error

Action

Advanced Bionics is notifying clinicians of this situation so that they can provide appropriate clinical management. The notification letter sent to clinicians in the United States was sent via FedEx so that delivery information could be confirmed. The letter advises that Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Auria and Harmony headpieces are not affected by this issue. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Since discovery of this issue firm has conducted an extensive technical analysis showing that the use of these headpieces does not pose any safety risk to the patient. While there has been no increase in the number of headpiece-related complaints, firm advises of the potential clinical symptoms: -No lock -Intermittent lock -Implant locks, but cannot measure impedances -Reduction in battery life, primarily for C1 patients with thick flaps. Per the letter, as long as the system maintains lock, there is no degradation in sound quality or stimulation. Further, the impact on battery life for CII and HiRes 90K patients is minimal. Medical professionals are advised that If they have any patients who display any of these clinical symptoms that they attribute to an affected headpiece, to advise the patient to contact Advanced Bionics Customer Service at 877-244-9541 and they will send them a replacement promptly.

Quantity

Model AB-5301-00: 119 units; Model AB-5301-10: 132 units

Distribution

Nationwide

Lot, serial or model codes

a) Model AB-5301-00 (biege); Serial Numbers: 14532, 14544, 14546, 14590, 14591, 14592, 14593, 14594, 14595, 14596, 14597, 14598, 14599, 14600, 14601, 14602, 14603, 14604, 14605, 14606, 14607, 14608, 14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14650, 14654, 14655, 14657, 14663, 14666, 14669, 14670, 14671, 14678, 14679, 14680, 14681, 14682, 14683, 14684, 14685, 14687, 14688, 14690, 14691, 14694, 14695, 14696, 14697, 14698, 14699, 14700, 14702, 14703, 14704, 14705, 14706, 14707, 14708, 14709, 15269, 15272, 15303, 15304, 15305, 15306, 15307, 15308, 15309, 15310, 15311, 15312, 15313, 15314, 15315, 15316, 15317, 15318, 15319, 15320, 15321, 15322, 15323, 15324, 15325, 15326, 15327, 15328, 15329, 15330, 15331, 15332, 15483, 15484, 15485, 15486, 15487, 15488, 15489, 15490, 15491, 15492, 15493, 15496, 15497, 15499, 15500, 15501, 15502 and 15504. b) Model AB-5301-10 (brown), Serial Numbers: 11112, 11113, 11114, 11115, 11121, 11123, 11124, 11125, 11126, 11129, 11160, 11161, 11163, 11164, 11165, 11166, 11167, 11169, 11170, 11171, 11172, 11173, 11174, 11175, 11176, 11177, 11178, 11179, 11180, 11181, 11182, 11183, 11184, 11185, 11186, 11188, 11189, 11190, 11191, 11196, 11201, 11208, 11215, 11216, 11217, 11218, 11250, 11251, 11254, 11255, 11256, 11257, 11259, 11260, 11261, 11262, 11263, 11265, 11267, 11269, 11270, 11271, 11272, 11273, 11274, 11275, 11277, 11278, 11280, 11281, 11282, 11283, 11284, 11285, 11286, 11287, 11288, 11289, 11290, 11291, 11292, 11293, 11294, 11295, 11296, 11297, 11298, 11299, 11300, 11301, 11302, 11303, 11304, 11305, 11306, 11307, 11308, 11309, 11324, 11325, 11326, 11327, 11328, 11329, 11330, 11331, 11332, 11333, 11334, 11406, 11413, 11414, 11416, 11418, 11430, 11432, 11435, 11437, 11438, 11439, 11443, 11445, 11446, 11449, 11452, 11453, 11454, 11499, 11501, 11508, 11510 and 11517.

510(k) numbers

not on file

PMA numbers

["P960058"]

Product code

MCM

Firm FEI

3006556115

Firm city

Sylmar

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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