FDA Device

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.

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