|
Class 2 Device Recall Blease Sirius Anaesthesia Systems |
|
Date Initiated by Firm |
June 25, 2009 |
Date Posted |
December 27, 2010 |
Recall Status1 |
Terminated 3 on December 28, 2010 |
Recall Number |
Z-0813-2011 |
Recall Event ID |
57348 |
510(K)Number |
K051629
|
Product Classification |
Gas-machine, anesthesia - Product Code BSZ
|
Product |
Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two anaesthetic vapourisers on the back bar via a demountable system. The delivery of anaesthetic agent is achieved by the rotation of a control knob which actuates a feature designed "shot bold" mechanism. The purpose of which is to prevent two vapourisers being turned on simultaneously..
The product is labeled in part: "BleaseSirius Anesthesia System...SPACELABS Healthcare...Blease Medical Equipment Limited Beech House, Chiltern Court, Asheridge Road, Chesham, Bucks HP5 2PX, England...Spacelabs Healthcare Company Headquarters 5150 220th Ave. SE, Issaquah, WA 98029 PO Box 7018, Issaquah, WA 98027-7018". |
Code Information |
Serial numbers: SIRI-000845, SIRI-000862, SIRI-000869, SIRI-000885, and SIRI-000898. |
Recalling Firm/ Manufacturer |
Spacelabs Healthcare, Llc 5150 220th Ave Se Issaquah WA 98029-6834
|
For Additional Information Contact |
425-657-7200 Ext. 5970
|
Manufacturer Reason for Recall |
Users may experience difficulty turning the control knob to an active vapour delivery setting, or may not be able to turn on the Left Hand mounted vapouriser on the Blease Sirius Anaesthesia Systems.
|
FDA Determined Cause 2 |
Other |
Action |
Spacelabs Healthcare issued an URGENT MEDICAL DEVICE CORRECTION letter dated June 25, 2009 to the two consignees in the US. Spacelabs Healthcare UK notified consignees outside the US.
The consignees were advised to brief their staff about the issue and test the Anesthesia Systems in advance of a procedure. If there is an issue with turning on a vaporizer in the left hand position, simply move the vaporizer to the right hand position.
The firm contacted their consignees for a schedule to replace the flowmeter mouldings.
The US consignees can contact Spacelabs Healthcare Representatives at 425-657-7200 ext. 5089 about this recall. Foreign consignees can contact Spoacelabs at 44 1494 784422. |
Quantity in Commerce |
5 units to US consignees and 36 units Internationally. |
Distribution |
Worldwide Distribution: US in the states of LA and SD, and internationally by Spacelabs Healthcare, Ltd in the countries of China, Czech Republic, Hong Kong, India, Poland, Saudi Arabia, Singapore, and the United Kingdom. |
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.
|
|
|
|