Recall Z-0813-2011 ยท BSZ Gas-Machine, Anesthesia
Spacelabs Healthcare, Llc
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
| Date | Dec 27, 2010 (initiated Jun 25, 2009) |
| Status | Terminated |
| Reason | 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. |
| 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 42 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051629 | BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 Blease USA, Inc., Sep 23, 2005 |