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Terminated

Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)

FDA Recall Z-0610-03 · Posted 2003-03-05

Recalling FirmDatex-Ohmeda
Recall StatusTerminated
Product CodeDQA
Date Initiated2002-09-16
Date Terminated2004-07-02
Product Quantity1019

Reason for Recall

Falsely high blood oxygen saturation readings in some circumstances could result in no alarm in a critical life-threatening situation.

Firm Action

'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.

Root Cause

Other

Distribution Pattern

Nationwide in the United States and worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011670DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCEDatex-Ohmeda · 2001-06-26K010463DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRESDatex-Ohmeda, Inc. · 2001-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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