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AG Module(O2/package/accessory)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Model 115-044874-00 · UDI-DI 06944904096636
CBR
Prescription
1
510(k) clearances
21
Adverse events
3
Recalls
55
Facilities
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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