Recall Z-0660-2008 ยท CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Spacelabs Healthcare, Incorporated
Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027
| Date | Jan 31, 2008 (initiated Oct 8, 2007) |
| Status | Terminated |
| Reason | Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa. |
| Root cause | Software design |
| 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. |
| Quantity | 722 devices |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053599 | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES Spacelabs Medical, Inc., Apr 19, 2006 |