Events

Recall of Device Recall Ultraview SL Patient Monitor, Model 91387

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
    58402
  • Event Risk Class
    Class 2
  • Event Number
    Z-2134-2011
  • Event Initiated Date
    2011-03-24
  • Event Date Posted
    2011-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99275
  • 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 circuit that supplies backup power to the modules in the medical patient monitor, model 91387, is not working. if there is a power interruption, the three-minute backup may not be operational and customers may lose any changes they have made to the alarm settings.
  • Action
    SPACELABS Healthcare sent an Urgent Medical Device Correction letter dated April 1, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to weigh the benefits versus the risks when deciding whether or not to continue to use their monitors until they can be upgraded. Customers were recommended to brief their staff about the possibility of losing changes to the alarm settings and to restore them after a power interruption. Field service engineers will contact customers to schedule a mutually agreeable time to come to their hospital and upgrade their affected patient monitors at no cost to the hospital. US Consignees can call 1-800-522-7025, Select 2 for Technical Support. Consignees outside of the US can call 1-425-657-7200 x5089 for any questions about this recall.

Device

Device Recall Ultraview SL Patient Monitor, Model 91387
  • Model / Serial
    Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01 (serial numbers beginning with 1387-1xxxxx).
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, Republic OF CHINA, Thailand, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA.AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, Republic OF CHINA, Thailand, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA.
  • Product Description
    Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496. || Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01 (serial numbers beginning with 1387-1xxxxx). || The data sheet is labeled in part: || "***91387-27 SL2700 Patient Monitor***91387-28 SL2800 Advanced Patient Monitor***91387-38 SL3800 Central Monitor***Spacelabs Healthcare ***Ultraview SL***The Ultraview SL 2700 and SL2800 bedside monitors include interactive networking, graphic and tabular trends, remote view and alarm watch support. They accommodate two single-high parameter modules, use external flat panel displays, and include a DC power supply that provides power for the monitor and up to three Flexoria¿ system interfaces. The SL3800 central monitor includes interactive networking, graphic and tabular trends, remote view, alarm watch, and central alarm manager. The central monitor accommodates a dual-high recorder module, uses an external flat panel display, and includes a DC power supply. In addition to central monitoring, the SL3800 provides bedside monitoring operation through Biomed-level control***". || Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexport 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. 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 (i.e. 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 net worked 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