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Devices
Device Recall SSeries Headpiece Short Range
모델명 / 제조번호(시리얼번호)
a) Model MMT-5300-00 (beige); Serial Numbers:14122, 14124, 14125, 14126, 14127, 14128, 14129, 14130, 14132, 14133, 14134, 14135, 14137, 14138, 14139, 14141, 14142, 14143, 14144, 14145, 14147, 14148, 14149, 14150, 14151, 14152, 14153, 14155, 14156, 14157, 14158, 14159, 14160, 14161, 14162, 14163, 14164, 14166, 14168, 14169, 14170, 14171, 14715, 14716, 14717, 14718, 14719, 14720, 14721, 14722, 14723, 14724, 14725, 14726, 14727, 14730, 14732, 14735, 14736, 14741, 14742, 14743, 14800, 14955, 14956, 14964, 14971, 15105, 15106, 15107, 15110, 15111, 15112, 15117, 15118 and 15120. b) Model MMT-5300-10 (brown); Serial Numbers: 10250, 10251, 10252, 10254, 10255, 10256, 10289, 10290, 10291, 10292, 10293, 10294, 10295, 10296, 10297, 10298, 10299, 10300, 10301, 10302, 10303, 10304, 10305, 10306, 10307, 10308, 10309, 10310, 10311, 10312, 10313, 10314, 10315, 10316, 10317, 10318, 10319, 10320, 10321, 10322, 10323, 10324, 10325, 10326, 10327, 10328, 10329, 10330, 10331, 10332, 10333, 10334, 10335, 10336, 10337, 10338, 10339, 10340, 10341, 10342, 10344, 10345, 10346, 10348, 10352, 10354, 10362, 10367, 10374, 10375, 10378, 10559, 10561, 10566, 10572, 10573, 10577, 10578, 10582, 10583, 10586, 10587, 10588, 10649, 10650, 10651, 10652, 10653, 10654, 10655, 10656, 10657, 10658, 10659, 10660, 10661, 10663, 10664, 10665, 10666, 10668, 10669, 10670, 10673, 10674, 10675, 10676, 10677, 10678, 10682, 10684, 10702, 10705, 10769, 10770, 10771, 10773 and 10774.
의료기기 분류등급
Ear, Nose, and Throat Devices
의료기기 등급
3
이식된 장치?
Yes
유통
Nationwide
제품 설명
S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (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.
Manufacturer
Advanced Bionics LLC
1 Event
Device Recall SSeries Headpiece Short Range 의 리콜
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제조사
Advanced Bionics LLC
제조사 주소
Advanced Bionics LLC, 12740 San Fernando Rd, Sylmar CA 91342-3728
제조사 모회사 (2017)
Sonova Holding Ag
Source
USFDA
Language
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