Events

Device Recall Ultraview SL 2200 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare, Incorporated 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    53779
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0647-2010
  • 사례 시작날짜
    2009-11-06
  • 사례 출판 날짜
    2010-01-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86500
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Medical Cathode-Ray Tube Display - Product Code DXJ
  • 원인
    Potential for monitor to shut down and not being able to power on again.
  • 조치
    On 11/6/09 the firm sent Urgent - Device Correction notifications to customers by certified mail informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. On 11/13/2009 the firm's Global Tech Support sent notification via email to all foreign subsidiaries and distributors informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. Questions are to be directed to Spacelabs Medical's Technical Support at 1-800-522-7025, and 1-425-657-7200 x5089 for those customers outside of the US.

Device

Device Recall Ultraview SL 2200
  • 모델명 / 제조번호(시리얼번호)
    S/N, U.S. Domestic units: 1367-000395, 1367-000396, 1367-000397, 1367-000628, 1367-000629, 1367-000630, 1367-000631, 1367-000632, 1367-000633, 1367-000522, 1367-000525, 1367-000526, 1367-000527, 1367-000601, 1367-000602, 1367-000603, 1367-000604, 1367-000605, 1367-000606, 1367-000477, 1367-000731, 1367-000732, 1367-000733, 1367-000734, 1367-000444, 1367-000831, 1367-000832, 1367-000833, 1367-000437, 1367-000438, 1367-000272, 1367-000454, 1367-000482, 1367-000483, 1367-000433, 1367-000434, 1367-000435, 1367-000436, 1367-000479, 1367-000480, 1367-000481, 1367-000524, 1367-000399, 1367-000400, 1367-000411, 1367-000412, 1367-000735, 1367-000736, 1367-000737, 1367-000738, 1367-000739, 1367-000740, 1367-000741, 1367-000742, 1367-000743, 1367-000744, 1367-000745, 1367-000746, 1367-000747, 1367-000748, 1367-000749, 1367-000439, 1367-000440, 1367-000441, 1367-000442, 1367-000443, 1367-000523, 1367-000530, 1367-000531, 1367-000532, 1367-000663, 1367-000664, 1367-000665, 1367-000691, 1367-000692, 1367-000693, 1367-000694, 1367-000695, 1367-000696, 1367-000697, 1367-000698, 1367-000699, 1367-000700, 1367-000701, 1367-000702, 1367-000703, 1367-000704, 1367-000705, 1367-000706, 1367-000707, 1367-000708, 1367-000709, 1367-000710, 1367-000711, 1367-000712, 1367-000713, 1367-000714, 1367-000715, 1367-000716, 1367-000717, 1367-000718, 1367-000719, 1367-000720, 1367-000528, 1367-000529, 1367-000486, 1367-000487, 1367-000635, 1367-000636, 1367-000637, 1367-000638, 1367-000639, 1367-000640, 1367-000641, 1367-000642, 1367-000643, 1367-000650, 1367-000651, 1367-000652, 1367-000653, 1367-000654, 1367-000655, 1367-000656, 1367-000657, 1367-000658, 1367-000659, 1367-000660, 1367-000661, 1367-000662, 1367-000398, 1367-000644, 1367-000645, 1367-000646, 1367-000647, 1367-000648, 1367-000649, 1367-000777, 1367-000834, 1367-000835, 1367-000836, 1367-000837, 1367-000838, 1367-000839, 1367-000427, 1367-000428, 1367-000429, 1367-000430, 1367-000431, 1367-000432, 1367-000721, 1367-000722, 1367-000723, 1367-000724, 1367-000725, 1367-000726, 1367-000727, 1367-000728, 1367-000729, 1367-000730, 1367-000445, 1367-000519, 1367-000582, 1367-000583, 1367-000584, 1367-000585, 1367-000586, 1367-000587, 1367-000588, 1367-000589, 1367-000590, 1367-000591, 1367-000592, 1367-000593, 1367-000666, 1367-000667, 1367-000668, 1367-000669, 1367-000670, 1367-000776, 1367-000779, 1367-000780, 1367-000781, 1367-000782, 1367-000783, 1367-000784, 1367-000785, 1367-000786, 1367-000787, 1367-000788, 1367-000789, 1367-000790, 1367-000791, 1367-000792, 1367-000793, 1367-000794, 1367-000795, 1367-000796, 1367-000797, 1367-000798, 1367-000799, 1367-000800, 1367-000801, 1367-000802, 1367-000803, 1367-000804, 1367-000805, 1367-000806, 1367-000807, 1367-000808, 1367-000809, 1367-000810, 1367-000811, 1367-000812, 1367-000813, 1367-000814, 1367-000815, 1367-000816, 1367-000817, 1367-000818, 1367-000819, 1367-000820, 1367-000821, 1367-000822, 1367-000823, 1367-000824, 1367-000825, 1367-000826, 1367-000827, 1367-000828, 1367-000829, 1367-000830, 1367-000571, 1367-000572, 1367-000573, 1367-000574, 1367-000575, 1367-000576, 1367-000577, 1367-000578, 1367-000579, 1367-000580, 1367-000581, 1367-000609, 1367-000610, 1367-000611, 1367-000612, 1367-000613, 1367-000614, 1367-000615, 1367-000616, 1367-000617, 1367-000618, 1367-000619, 1367-000620, 1367-000621, 1367-000622, 1367-000623, 1367-000624, 1367-000625, 1367-000626, 1367-000627, 1367-000520, 1367-000750, 1367-000751, 1367-000752, 1367-000753, 1367-000754, 1367-000755, 1367-000756, 1367-000757, 1367-000758, 1367-000759, 1367-000760, 1367-000761, 1367-000762, 1367-000763, 1367-000764, 1367-000765, 1367-000243, 1367-000671, 1367-000672, 1367-000673, 1367-000674, 1367-000675, 1367-000676, 1367-000677, 1367-000678, 1367-000679, 1367-000680, 1367-000681, 1367-000682, 1367-000684, 1367-000685, 1367-000686, 1367-000687, 1367-000688, 1367-000689, 1367-000690, 1367-000607, 1367-000608, 1367-000771, 1367-000772, 1367-000774, 1367-000775, 1367-000450, 1367-000451, 1367-000452, 1367-000453.  Foreign units:, 1367-000447, 1367-000448, 1367-000449, 1367-000484, 1367-000488, 1367-000251, 1367-000413, 1367-000414, 1367-000415, 1367-000446, 1367-000455, 1367-000456, 1367-000457, 1367-000458, 1367-000459, 1367-000460, 1367-000461, 1367-000462, 1367-000463, 1367-000464, 1367-000465, 1367-000466, 1367-000467, 1367-000468, 1367-000469, 1367-000470, 1367-000471, 1367-000472, 1367-000473, 1367-000474, 1367-000475, 1367-000476, 1367-000478, 1367-000485, 1367-000489, 1367-000490, 1367-000491, 1367-000492, 1367-000493, 1367-000494, 1367-000495, 1367-000496, 1367-000497, 1367-000498, 1367-000499, 1367-000500, 1367-000501, 1367-000502, 1367-000503, 1367-000504, 1367-000505, 1367-000506, 1367-000507, 1367-000508, 1367-000509, 1367-000510, 1367-000511, 1367-000512, 1367-000513, 1367-000514, 1367-000515, 1367-000516, 1367-000517, 1367-000518, 1367-000521, 1367-000533, 1367-000534, 1367-000535, 1367-000536, 1367-000537, 1367-000538, 1367-000539, 1367-000540, 1367-000541, 1367-000542, 1367-000543, 1367-000544, 1367-000545, 1367-000546, 1367-000547, 1367-000548, 1367-000549, 1367-000550, 1367-000551, 1367-000552, 1367-000553, 1367-000554, 1367-000555, 1367-000556, 1367-000557, 1367-000558, 1367-000559, 1367-000560, 1367-000561, 1367-000562, 1367-000563, 1367-000564, 1367-000565, 1367-000566, 1367-000567, 1367-000568, 1367-000569, 1367-000570, 1367-000595, 1367-000596, 1367-000597, 1367-000598, 1367-000599, 1367-000600, 1367-000634, 1367-000683, 1367-000769, 1367-000770, and 1367-000773.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Spacelabs Model 91367 SL 2200 Compact Monitor || Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

Spacelabs Healthcare, Incorporated
  • 제조사 주소
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA