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Terminated

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".

FDA Recall Z-0813-2011 · Posted 2010-12-27

Recalling FirmSpacelabs Healthcare, Llc
Recall StatusTerminated
Product CodeBSZ
Date Initiated2009-06-25
Date Terminated2010-12-28
Product Quantity5 units to US consignees and 36 units Internationally.

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051629BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000Blease USA, Inc. · 2005-09-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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