Events

Recall of Device Recall Spacelabs Medical Patient Monitor

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

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
    59456
  • Event Risk Class
    Class 2
  • Event Number
    Z-3032-2011
  • Event Initiated Date
    2011-07-08
  • Event Date Posted
    2011-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102834
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    The clinician did not realize the monitor was in end case mode and was expecting audible alarms. visual alarms continue to work normally.
  • Action
    Spacelabs sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated July 25, 2011 along with the Perioperative section of the Operations Manual to all consignees in the US. This letter includes recalled model 91369, 91370, 91387, & 91393 (option D). On July 27, 2011, Spacelabs sent out an updated recall notification letter to include one additional model 91367 to all consignees in the US. The letter identifies the products, problem, and actions to be taken. On August 2, 2011, a recall notification letter (translated as necessary) and the Perioperative section of the Operations Manual was emailed to all international subsidiaries and distributors of record. The notification letter stated that the Operating Room staff may not be aware that alarm tones are off if the device has been left in the END CASE state. If the customers make use of the Perioperative START CASE / END CASE feature, they should advise the clinicians to familiarize themselves with this feature as described in the Perioperative section of the Operations Manual. In particular, they should know how to confirm the state of the alarm tones prior to starting a case. The letter states that the firm is in the process of upgrading the software and will be contacting customers to update monitors at no cost. If customers have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support, or outside the United States 1-425-657-7200 x5089.

Device

Device Recall Spacelabs Medical Patient Monitor
  • Model / Serial
    Serial numbers:  1367-000023, 1367-000234, 1367-000237, 1367-000238, 1367-000272, 1367-000279, 1367-000280, 1367-000281, 1367-000282, 1367-000283, 1367-000284, 1367-000361, 1367-000368, 1367-000369, 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, 1367-001052, 1367-001198, 1367-001344, 1369-001517, 1369-003041, 1369-003077, 1369-003141, 1369-003215, 1369-003596, 1369-003598, 1369-004170, 1369-004217, 1369-004247, 1369-004868, 1369-005316, 1369-005334, 1369-005561, 1369-005562, 1369-005676, 1369-005744, 1369-005745, 1369-005746, 1369-005911, 1369-005912, 1369-005913, 1369-005914, 1369-005918, 1369-005919, 1369-005920, 1369-005921, 1369-006100, 1369-006132, 1369-006143, 1369-006223, 1369-006224, 1369-006281, 1369-006365, 1369-006366, 1369-006380, 1369-006641, 1369-006643, 1369-006829, 1369-006860, 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1387-101409, 1387-101410, 1387-101418, 1387-101419, 1387-101701, 1387-101702, 1387-101703, 1387-101704, 1387-101705, 1387-101706, 1387-101727, 1387-101728, 1387-101729, 1387-101852, 1387-101853, 1387-101854, 1387-102044, 1387-102092, 1387-102093, 1387-102094, 1387-102095, 1387-102096, 1387-102097, 1387-102098, 1387-102099, 1387-102100, 1387-102101, 1387-102102, 1387-102104, 1387-102105, 1387-102106, 1387-102107, 1387-102108, 1387-102135, 1387-102136, 1387-102137, 1387-102138, 1387-102139, 1387-102140, 1387-102141, 1387-102142, 1387-102143, 1387-102144, 1387-102145, 1387-102146, 1387-102159, 1387-102162, 1387-102197, 1387-102198, 1387-102221, 1387-102222, 1387-102442, 1387-102443, 1387-102444, 1387-102498, 1387-102499, 1387-102514, 1387-102515, 1387-102533, 1387-102540, 1387-102541, 1387-102542, 1387-102549, 1387-102550, 1387-102551, 1387-102552, 1387-102553, 1387-102601, 1387-102602, 1387-102603, 1387-102604, 1387-102605, 1387-102606, 1387-102608, 1387-102609, 1387-102610, 1387-102611, 1387-102612, 1387-102616, 1387-102812, 1387-102813, 1387-102953, 1387-103011, 1387-103035, 1387-103182, 1387-103183, 1387-103202, 1387-103310, 1387-103341, 1387-103342, 1387-103343, 1387-103344, 1387-103345, 1387-103346, 1387-103347, 1387-103348, 1387-103349, 1387-103350, 1387-103351, 1387-103357, 1387-103358, 1387-103359, 1387-103360, 1387-103361, 1387-103362, 1387-103438, 1387-103439, 1387-103457, 1387-103458, 1387-103459, 1387-103460, 1387-103461, 1387-103462, 1387-103463, 1387-103464, 1387-103465, 1387-103466, 1387-103518, 1387-103535, 1387-103536, 1387-103537, 1387-103538, 1387-103539, 1387-103540, 1387-103541, 1387-103542, 1387-103543, 1387-103544, 1387-103545, 1387-103546, 1387-103547, 1387-103548, 1387-103549, 1387-103550, 1387-103551, 1387-103604, 1387-103605, 1387-103606, 1387-103607, 1387-103608, 1387-103609, 1387-103659, 1387-103660, 1387-103661, 1387-103662, 1387-103663, 1387-103664, 1387-103665, 1387-103666, 1387-103749, 1387-103797, 1387-103798, 1387-103799, 1387-103800, 1387-103801, 1387-103802, 1387-103803, 1387-103815, 1387-103816, 1387-103823, 1387-103824, 1387-103825, 1387-103826, 1387-103827, 1387-103828, 1387-103829, 1387-103830, 1387-103831, 1387-103832, 1387-103833, 1387-103834, 1387-103835, 1387-103836, 1387-103837, 1387-103838, 1387-103839, 1387-103840, 1387-103841, 1387-103842, 1387-103843, 1387-103844, 1387-103846, 1387-103847, 1387-103848, 1387-103849, 1387-103850, 1387-103851, 1387-103852, 1387-103853, 1387-103854, 1387-103855, 1387-103856, 1387-103857, 1387-103884, 1387-103885, 1387-103886, 1387-103887, 1387-103888, 1387-104021, 1387-104022, 1387-104023, 1387-104024, 1387-104106, 1387-104223, 1387-104308, 1387-104309, 1387-104310, 1387-104311, 1387-104312, 1387-104313, 1387-104392, 1387-104393, 1387-104394, 1387-104395, 1387-104396, 1387-104397, 1387-104398, 1387-104399, 1387-104400, 1387-104403, 1387-104404, 1387-104405, 1387-104406, 1387-104407, 1387-104428, 1387-104462, 1387-104579, 1387-104580, 1387-104587, 1387-104590, 1387-104672, 1387-104697, 1387-104727, 1387-104728, 1387-104729, 1387-104730, 1387-104731, 1387-104732, 1387-104733, 1387-104734, 1387-104735, 1387-104736, 1387-104742, 1387-104760, 1387-104761, 1387-104850, 1387-104851, 1387-104852, 1387-104853, 1387-104883, 1387-104885, 1387-104905, 1387-104908, 1387-104952, 1387-104953, 1387-104977, 1387-104978, 1387-105013, 1387-105019, 1387-105028, 1387-105032, 1387-105093, 1387-105094, 1387-105095, 1387-105096, 1387-105098, 1387-105117, 1387-105118, 1387-105120, 1387-105134, 1387-105135, 1387-105137, 1387-105276, 1387-105342, 1387-105343, 1387-105466, 1387-105467, 1387-105468, 1387-105469, 1387-105478, 1387-105479, 1387-105480, 1387-105681, 1387-105682, 1387-105683, 1387-105684, 1387-105687, 1387-105696, 1387-105697, 1387-105698, 1387-105699, 1387-105700, 1387-105701, 1387-105702, 1387-105703, 1387-105704, 1387-105727, 1387-105728, 1393-000013, 1393-000039, 1393-000040, 1393-000041, 1393-000062, 1393-000063, 1393-000064, 1393-000065, 1393-000066, 1393-000067, 1393-000068, 1393-000069, 1393-000070, 1393-000071, 1393-000096, 1393-000097, 1393-000113, 1393-000114, 1393-000115, 1393-000116, 1393-000117, 1393-000118, 1393-000119, 1393-000120, 1393-000121, 1393-000122, 1393-000123, 1393-000124, 1393-000125, 1393-000126, 1393-000127, 1393-000128, 1393-000129, 1393-000130, 1393-000228, 1393-000229, 1393-000382, 1393-000383, 1393-000384, 1393-000385, 1393-000386, 1393-000387, 1393-000388, 1393-000517, 1393-000518, 1393-000519, 1393-000520, 1393-000521, 1393-000522, 1393-000523, 1393-000524, 1393-000525, 1393-000548, 1393-000549, 1393-000550, 1393-000620, 1393-000621, 1393-000774, 1393-000775, 1393-000776, 1393-000777, 1393-000778, 1393-000779, 1393-000780, 1393-000782, 1393-000808, 1393-000809, 1393-00235, 1393-00236, 1393-00237, 1393-00238,  1393-00239, 1393-00240, 1393-00241, 1393-00335, 1393-00346,  1393-00347, 1393-00348, 1393-00349, 1393-00350, 1393-00351,  1393-00352, 1393-00353, 1393-00354, and 1393-00355.   Additional serial numbers provided on 9/22/11: D5129719, S5116918, S5129089, S5132098, S5132108, S5132142, S5132754, S5134828, S5135370, S5139030, S5139569, S5142218, S5144443, S5154715, S5156840, S5157705, S5159595, S5164214, S5174050, S5185302, S5188765, S5348911, S5354947, S5368108, S5373811, and S5418867.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Australia, Bahrain, Bolivia, Brazil, Canada, Caymen Island, Chile, China, Colombia, Cyprus, Ecuador, Finland, France, Germany, Guam, India, Indonesia, Israel, Italy, Jordan, Mexico, Morocco, New Zealand, Nicaragua, Pakistan, Paraguay, Peru, Philippines, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, Uruguay, and Venezuela.
  • Product Description
    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, & 91393 are sold with with Perioperative Mode (option D), which includes Start case/End case functionality. || Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. || Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. || Product Usage: When a clinician enters END CASE mode, there is the expectation the operation is over and the patient is being disconnected from the monitor. Removing the patient cables will trigger multiple alarms so clinicians will enter this END CASE mode to prevent having to listen to false alarms. Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine: a) when an alarm condition is violated; b) the alarm priority (ie. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open Windows and display information on other net worked monitors. Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Manufacturer Address
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    USFDA