Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Se

FDA device recall Z-0968-2013 · posted 2013-03-20 · Terminated

Recall details

Recalling firm

Del Mar Reynolds Medical, Ltd.

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.

Action taken

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

Status

Terminated

Product code

CBK

Quantity affected

108 total (17 units in the US and 91 units outside the US)

Distribution

Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.

Date initiated

2013-01-15

Date posted

2013-03-20

Date terminated

2013-05-14

Location

Hertford, United Kingdom

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