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U.S. Department of Health and Human Services

Class 2 Device Recall BleaseSirius Anaesthesia Machine

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  Class 2 Device Recall BleaseSirius Anaesthesia Machine see related information
Date Initiated by Firm June 24, 2010
Date Posting Updated July 29, 2010
Recall Status1 Terminated 3 on December 03, 2010
Recall Number Z-2113-2010
Recall Event ID 56057
510(K)Number K051629  
Product Classification Anesthesia Gas-Machine - Product Code BSZ
Product 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.
Code Information 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.
Recalling Firm/
Spacelabs Healthcare, Llc
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information Contact David J. Geraghty
425-657-7200 Ext. 5809
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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.
Quantity in Commerce 80 units total
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = BLEASE USA, INC.