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Terminated

Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5

FDA Recall Z-1049-04 · Posted 2004-07-20

Recalling FirmRespironics Novametrix, Inc.
Recall StatusTerminated
Product CodeDQA
Date Initiated2002-09-02
Date Terminated2004-07-06
Product Quantity901 units

Reason for Recall

Audio alarm may fail to sound when SpO2 limits drop below the set limits

Firm Action

Respironics notified customers by letter dated 9/3/02 of the problem with the failure of the audible alarm. A correction would require replacement of the speaker. Non-responders were recontacted by second letter on 2/24/2004.

Root Cause

Other

Distribution Pattern

AK, AZ, CA, CT, FL, NY, NM, PA, OK, TX,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032755MODEL 509M PULSE OXIMETER, MODEL 509MRespironics Novametrix, Inc. · 2004-05-21K000794MODIFICATION TO MARSPO2, MODEL 2001Novametrix Medical Systems, Inc. · 2000-04-10K993979MARSPO2, MODEL 2001Novametrix Medical Systems, Inc. · 2000-02-22

Official Source

View FDA Recall →

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

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