Events

Recall of Device Recall BleaseSirius Anaesthesia Machine

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
    56057
  • Event Risk Class
    Class 2
  • Event Number
    Z-2113-2010
  • Event Initiated Date
    2010-06-24
  • Event Date Posted
    2010-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92556
  • 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
    Anesthesia Gas-Machine - Product Code BSZ
  • Reason
    Potential for the touch screen on the ventilator portion of the device to go blank when touched. possibility that this failure may also cause mechanical ventilation to stop.
  • Action
    On 06/24/2010, Spacelabs began mailing the URGENT-MEDICAL DEVICE CORRECTION letter to their US consignees and e-mailed the same letter to their foreign consignees. The letter describes the touch screen of the BleaseSirius Anesthesia machine goes blank when touched and the possibility that this failure may cause the mechanical ventilation to stop. The consignees are asked to weigh the benefits versus the risk when deciding to use the device or not until the firm upgrades the device. The letter also instructs the consignees to notify their staff about the possibility of the display failure to prevent any adverse event that may occur. The letter states that their field service engineer will contact consignees to schedule a time to visit and upgrade all affected devices at no cost. The US consignees are advised to call 1-800-522-7025, Select 2, and the foreign consignees are advised to call 1-425-657-7200 x5089 for technical support or questions regarding the recall.

Device

Device Recall BleaseSirius Anaesthesia Machine
  • Model / Serial
    Serial numbers: DOMESTIC - siri-001852, siri-002292, SIRI-002081, SIRI-002082, SIRI-002085, SIRI-002089, SIRI-002091, SIRI-002097, SIRI-002099, SIRI-002101, SIRI-002102, SIRI-001851, SIRI-001818, SIRI-001819, SIRI-001821, SIRI-001822, SIRI-001823, SIRI-001824, SIRI-001825, SIRI-001826, SIRI-001827, SIRI-001828, SIRI-001829, SIRI-002106, and SIRI-002108.   INTERNATIONAL - siri-001861, siri-001853, siri-001855, siri-001857, SIRI-001905, SIRI-002363, SIRI-001948, SIRI-001949, SIRI-001950, SIRI-001951, SIRI-001952, SIRI-001846, SIRI-001847, SIRI-001848, SIRI-001849, SIRI-001921, SIRI-001961, SIRI-001963, SIRI-001964, siri-002139, SIRI-002162, SIRI-002298, SIRI-002349, SIRI-002354, SIRI-001611, SIRI-001612, SIRI-001614, SIRI-001615, SIRI-001616, SIRI-001617, SIRI-002157, siri-002135, SIRI-2302, siri-001903, siri-001904, siri-001911, SIRI-002041, SIRI-001858, SIRI -002150, SIRI-002156, siri-002166, siri-002168, siri-002169, siri-002171, siri-002201, SIRI-001854, SIRI-001785, SIRI-001786, SIRI-001954, SIRI-001850, SIRI-001862, SIRI-002159, SIRI-002304, SIRI-002315, and SIRI-002224.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of IA, GA, LA, NC, TN, and TX and countries of AUSTRALIA, CHILE, CHINA, INDIA, ITALY, PHILIPPINES, MEXICO, POLAND, SINGAPORE, THAILAND, TURKEY, UNITED KINGDOM, and VENEZUELA.
  • Product Description
    BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England || Intended for use in the hospital environment and operating room.
  • 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