Events

Recall of Device Recall Ultraview Digital Telemetry Transmitter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spacelabs Healthcare, Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    48985
  • Event Risk Class
    Class 2
  • Event Number
    Z-1652-2008
  • Event Initiated Date
    2008-07-18
  • Event Date Posted
    2008-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72451
  • Notes / Alerts
    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.
  • Extra notes in the data
    Telemetry Reciever - Product Code DSI
  • Reason
    Telemetry modules are failing to alarm for low heart rate and asystole.
  • Action
    On 07/18/08 Spacelabs Healthcare issued a "URGENT-MEDICAL DEVICE CORRECTION" letter, dated July 16, 2008, to all customers who received the Spacelabs Medical Telemetry Receiver-Model 90478. The letter states circumstances in which the alarm fails, how to test each module for high rate alarm prior to patient use and a temporary work around if the alarm failure exists.` Letters have a receipt acknowledgement to ensure each customer receives the letter. Spacelabs Technical Support will personally install the new software, version V3.05.07EN, in all Spacelabs Medical Telemetry Receivers Model 90478. Technical Support will also be responsible for responding to customer technical questions and ensuring each customer is upgraded regarding this medical device recall. For assistance contact SpaceLabs Medical at 1-425-657-7200.

Device

Device Recall Ultraview Digital Telemetry Transmitter
  • Model / Serial
    Serial Numbers 478-111508, 478-111509, 478-111510, 478-111511, 478-111962, 478-111963, 478-111964, 478-111965 478-114831, 478-117016, 478-117395, 478-117602, 478-122332, 478-122333, 478-122535, 478-124039, 478-124040, 478-124042, 478-124055, 478-108923, 478-108924, 478-108925, 478-108926, 478-108927, 478-108928, 478-108929, 478-108930, 478-112419, 478-112420, 478-112421, 478-112422, 478-114943, 478-114944, 478-114945, 478-114946, 478-114947, 478-114948, 478-114949, 478-114950, 478-114951, 478-114952, 478-122698, 478-122704, 478-122711, 478-137602, 478-137603, 478-144927 478-122680, 478-122680, 478-122680, 478-122680, 478-128481, 478-128483, 478-128515, 478-128525, 478-112052, 478-113089, 478-113097, 478-113704, 470-110122, 478-110126, 478-110939, 478-110940, 478-113098, 478-113099, 478-113101, 478-120415, 478-122158, 478-122159, 478-122163, 478-124049, 478-124057, 478-124058, 478-124570, 478-124571, 478-124994, 478-124996, 478-113527, 478-113528, 478-113529, 478-113530, 478-113531, 478-113532, 478-113533, 478-113761, 478-111405, 478-111803, 478-111827, 478-111828, 478-111829, 478-111836, 478-111837, 478-111838, 478-111839, 478-111840, 478-111841, 478-111842, 478-111843, 478-111844, 478-111845, 478-111846, 478-111847, 478-111848, 478-111849, 478-111850, 478-111851, 478-111852, 478-111853, 478-111854, 478-111887, 478-111888, 478-111996, 478-112013, 478-112014, 478-112016, 478-118020, 478-118367, 478-119474, 478-119475, 478-122679, 478-122685, 478-122687, 478-122688, 478-122691, 478-122692, 478-124272, 478-124274, 478-124723, 478-124724, 478-124725, 478-124726, 478-124732, 478-124733, 478-124734, 478-124735, 478-124736, 478-124739, 478-124740, 478-124741, 478-124742, 478-124743, 478-124748, 478-124750, 478-124751, 478-124762, 478-127124, 478-127129, 478-127155, 478-127473, 478-127997, 478-128063, 478-128067, 478-128528, 478-114841, 478-114866, 478-114868, 478-114869, 478-114870, 478-114871, 478-114872, 478-114873, 478-105101, 478-105145, 478-105269, 478-105481, 478-105531, 478-105617, 478-105634, 478-106017, 478-110011, 478-110012, 478-110013, 478-110024, 478-110025, 478-111180, 478-115421, 478-113006, 478-113007, 478-113008, 478-113010, 478-115358, 478-117023, 478-117034, 478-117074, 478-118351, 478-118352, 478-122327, 478-122329, 478-123849, 478-123854, 478-123941, 478-123949, 478-128001 478-129153 478-120034, 478-120040, 478-120041, 478-120047, 478-106809, 478-106810, 478-105975, 478-110117, 478-110123, 478-115390, 478-115426, 478-116810, 478-116817, 478-116824, 478-117122, 478-117126, 478-117127, 478-118041, 478-118256, 478-124126, 478-124127, 478-124128, 478-124331, 478-125680, 478-125681, 478-125682, 478-128661, 478-128662, 478-128665, 478-128667, 478-129167, 478-129684, 478-129687, 478-129691 478-129949 478-132784, 478-132785, 478-127983, 478-127985, 478-127990, 478-127991, 478-127993, 478-127994, 478-127995, 478-128020, 478-107614, 478-107615, 478-107616, 478-107617, 478-107618, 478-107613, 478-100222, 478-100501, 478-105173, 478-105174, 478-108214, 478-108353, 478-108527, 478-108648, 478-128336, 478-128337, 478-128548, 478-128551, 478-128552, 478-128555, 478-128556, 478-128557, 478-127070, 478-127083, 478-128450, 478-128487, 478-110116, 478-110192, 478-110193, 478-110194, 478-110238, 478-130761, 478-131067, 478-131068, 478-131070, 478-131071, 478-131072, 478-130563, 478-130773, 478-130774, 478-130775, 478-130776, 478-130777, 478-130778, 478-130779, 478-130780, 478-130781, 478-130782, 478-131692, 478-131693, 478-132052, 478-132236, 478-132779, 478-132795, 478-132796, 478-132797, 478-132798, 478-132799, 478-132800, 478-132801, 478-132802, 478-134083, 478-134084, 478-134085, 478-134086, 478-134087, 478-134088, 478-134089, 478-134090, 478-134091, 478-131671, 478-132283, 478-132287, 478-132320, 478-132321, 478-132695, 478-132696, 478-132697, 478-132698, 478-132699, 478-132700, 478-132701, 478-132702, 478-132703, 478-132704, 478-132705, 478-132706, 478-132707, 478-132708, 478-132709, 478-132710, 478-132711, 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478-124989, 478-125008, 478-125631, 478-125632, 478-141804, 478-141805, 478-141806, 478-141807, 478-141808, 478-141809, 478-141810, 478-141811, 478-141812, 478-141813, 478-141814, 478-141816, 478-143399, 478-143400, 478-143401, 478-143402, 478-146839, 478-146840, 478-146841, 478-146842, 478-146844, 478-146845, 478-146846, 478-146847, 478-146848, 478-146849, 478-146850, 478-146851 478-110624, 478-110968, 478-113052, 478-113053, 478-113090, 478-113091, 478-113092, 478-113093, 478-113094, 478-113111, 478-113112, 478-115377, 478-115395, 478-115397, 478-115400, 478-115402, 478-115404, 478-115405, 478-115417, 478-115418, 478-115419, 478-115420, 478-115422 478-113599, 478-113600, 478-117388, 478-117391, 478-118780, 478-118781, 478-118784, 478-118785, 478-122162, 478-122164 478-108544, 478-108545, 478-111549, 478-111550, 478-111552, 478-111555, 478-111557, 478-111558, 478-111559, 478-111560, 478-144585 478-117158, 478-117804, 478-117805, 478-117806, 478-117807, 478-117808, 478-117809, 478-117810, 478-117811, 478-122542, 478-122543 478-130293 478-111709, 478-111858, 478-111859, 478-111860, 478-111861, 478-111862, 478-115005, 478-115334, 478-116340, 478-117533, 478-117534, 478-117535, 478-117536, 478-117537, 478-117538, 478-117764 478-117134, 478-118259, 478-118260, 478-119686, 478-122224, 478-122225, 478-122226, 478-122231 478-125078, 478-128335, 478-128340 478-130301, 478-130882, 478-132238, 478-132248, 478-132268, 478-132282, 478-132285 478-109902, 478-109904, 478-109905, 478-109906, 478-109935, 478-109936, 478-110120, 478-110121, 478-110318, 478-110319, 478-111042, 478-111043 478-129946, 478-129947, 478-129951, 478-130520 478-128333, 478-128545, 478-128546, 478-128547, 478-129165, 478-129168, 478-129169, 478-129172 478-108772, 478-108777, 478-108789, 478-108931, 478-108932, 478-108933, 478-108935, 478-108936, 478-108937, 478-108938, 478-108939, 478-111823, 478-111824, 478-111825, 478-111826, 478-115437, 478-115438, 478-111894, 478-111895, 478-111896, 478-111897, 478-142240, 478-142241, 478-142242, 478-142243, 478-143973, 478-143978, 478-146906, 478-146907, 478-146908, 478-146910 478-106050, 478-106063 478-110203, 478-110450, 478-110458, 478-110598, 478-115844, 478-116162, 478-116163, 478-116271, 478-122862, 478-122873, 478-122875, 478-122876, 478-136422, 478-136423, 478-136424, 478-136425, 478-136426, 478-136427, 478-136428, 478-136431, 478-145278, 478-145322, 478-145323, 478-145552, 478-146101, 478-146167, 478-146952, 478-147043, 478-147070, 478-147153, 478-147164, 478-147165 478-112023, 478-113451, 478-113452, 478-113453, 478-113455, 478-113456, 478-113457, 478-113458, 478-113459, 478-119358, 478-119359, 478-122700, 478-122701 478-128338, 478-128339, 478-128341, 478-128342 478-112793, 478-112794, 478-116378, 478-124853, 478-126549, 478-126551, 478-126553, 478-126556, 478-126557, 478-126856, 478-126862, 478-126870, 478-126894 478-115231, 478-115234, 478-115287, 478-115293, 478-115294, 478-115295, 478-115296, 478-115351, 478-117720, 478-132714, 478-132732, 478-133975, 478-133976 478-125684, 478-125687 478-116797, 478-116798 478-145297, 478-145298, 478-145299, 478-145300, 478-145301 478-110493, 478-112048, 478-113096, 478-114216, 478-121458, 478-121459, 478-122161, 478-122165, 478-132730, 478-132731, 478-132733, 478-132734, 478-133326, 478-133327 478-141815, 478-142590, 478-142602 478-113727, 478-113795, 478-113796, 478-113798, 478-129381, 478-129796, 478-129797, 478-129883, 478-129884, 478-129885, 478-129886, 478-129887, 478-129888, 478-129889, 478-129890, 478-129892, 478-129355, 478-129444, 478-105999, 478-130223, 478-109741, 478-109763, 478-109773, 478-109774, 478-109775, 478-109776, 478-109777, 478-109778, 478-111498, 478-111612, 478-111613, 478-111614, 478-111615, 478-111617, 478-111657, 478-111702, 478-111705, 478-111733, 478-112260, 478-112262, 478-113287, 478-113535, 478-113536, 478-113537, 478-113538, 478-113539, 478-113540, 478-113541, 478-113542, 478-113543, 478-113544, 478-113545, 478-113546, 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  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Internationally
  • Product Description
    Ultraview Digital Telemetry Transmitter, Model 90478 || The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal cardiac rhythms, including asystole, ventricular fibrillation and ventricular tachycardia.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

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