Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027
FDA device recall Z-0660-2008 · posted 2008-01-31 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Incorporated
- Reason for recall
- Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa.
- Action taken
- 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
- Status
- Terminated
- Product code
- CBR
- Quantity affected
- 722 devices
- Distribution
- Worldwide
- Date initiated
- 2007-10-08
- Date posted
- 2008-01-31
- Date terminated
- 2011-04-12
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES (K053599) | Spacelabs Medical, Inc. | 2006-04-19 |