Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two anaesthetic va
FDA device recall Z-0813-2011 · posted 2010-12-27 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 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, an
- Date initiated
- 2009-06-25
- Date posted
- 2010-12-27
- Date terminated
- 2010-12-28
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 (K051629) | Blease USA, Inc. | 2005-09-23 |