Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.
FDA Recall Z-0968-2013 · Posted 2013-03-20
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Recalling FirmDel Mar Reynolds Medical, Ltd.
Recall StatusTerminated
Product CodeCBK
Date Initiated2013-01-15
Date Terminated2013-05-14
Product Quantity108 total (17 units in the US and 91 units outside the US)
Reason for Recall
A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.
Firm Action
Spacelabs sent an URGENT-MEDICAL DEVICE CORRECTION letter, dated 16 January 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers until a Spacelabs representative replaces the affected product:
1) Immediately cease the use of BleaseSirius and BleaseFocus Anesthesia Workstations that shipped after 31 October 2012.
2) Immediately cease use of Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation containing a CAS I/II Absorber from such Service Kit.
3) Advise your staff of this situation
Customers can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical support.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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