Z-0813-2011

Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two...

Name: Z-0813-2011 Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two...
Creator: Spacelabs Healthcare, Llc
Published: 2009-06-25
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-06-25 / Terminated

FDA source

Spacelabs Healthcare, Llc began a recall of 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... on 2009-06-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0813-2011
Status: Terminated
Initiated: 2009-06-25
Posted: 2010-12-27
Terminated: 2010-12-28
Recalling firm: GE Healthcare
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".
Product code: BSZ Gas-Machine, Anesthesia
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 root cause: 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.
Product codes and lots: Serial numbers: SIRI-000845, SIRI-000862, SIRI-000869, SIRI-000885, and SIRI-000898.

Product code BSZ

K051629Class IIBleas Esiriuc Anaesthsia System, Models 3000, 2000Blease USA, Inc. / cleared 2005-09-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)