Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027
FDA Recall Z-0660-2008 · Posted 2008-01-31
Recalling FirmSpacelabs Healthcare, Incorporated
Recall StatusTerminated
Product CodeCBR
Date Initiated2007-10-08
Date Terminated2011-04-12
Product Quantity722 devices
Reason for Recall
Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa.
Firm Action
The firm sent out their Urgent Medical Device correction/recall letters on 10/5/2007, and an updated versions on 11/30/07 and 12/7/2007, forwarding an attached set of work around directions for use and associated tables for calculations. This short term fix will be updated to a permanent fix when a new software revision is released and installed at no cost to each user as noted in the recall notification. Telephone contact was provided at 1-800-522-7025.
Root Cause
Software design
Distribution Pattern
Worldwide
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.