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GE Healthcare Finland Oy · Model E-sCAiOV-00 · UDI-DI 00840682104142
5
510(k) clearances
21
Adverse events
3
Recalls
55
Facilities
Description
E-SCAIOV-00, MODULE ASSEMBLY
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-06-18 | Spacelabs Healthcare Inc | With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid. |
| 2011-06-08 | Spacelabs Healthcare, Llc | 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 o |
| 2007-10-08 | Spacelabs Healthcare, Incorporated | Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.