Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)
Hazard
Falsely high blood oxygen saturation readings in some circumstances could result in no alarm in a critical life-threatening situation.
What You Should Do
Remedy
'Medical Device Advisory Notice' letters dated September 16, 2002 were sent to the consignees, gave recommendations about alternative monitoring for certain patients, and stated that there would be a field correction to reduce the possibility of the problem.
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Products
Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)
- Brand
- Datex-Ohmeda
- UPC
- All serial numbers of the units distributed prior to the recall. September 16, 2002
Units Affected
1019