Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare Llc. Monitors gas concentrati
FDA device recall Z-2902-2011 · posted 2011-08-01 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- Reason for recall
- Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data.
- Action taken
- Spacelabs Healthcare, Llc. sent a "Customer Bulletin" dated June 20, 2011 to all affected customers. The customers were notified of the trend problem and are advised to follow the instructions in the Perioperative section and the ADMIT/DISCHARGE section of the users manual. For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support or 1-425-657-7200 x5089.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CBR
- Quantity affected
- 481 units worldwide (333 units internationally and 148 units in the US)
- Distribution
- Worldwide Distribution: (USA) Nationwide distribution, and the countries of ARGENTINA, BAHRAIN, BOLIVIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, ECUADOR, EGYPT, FRANCE, INDIA, MEXICO, NICARAGU
- Date initiated
- 2011-06-08
- Date posted
- 2011-08-01
- Date terminated
- 2011-09-21
- Location
- Issaquah, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES (K053599) | Spacelabs Medical, Inc. | 2006-04-19 |