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Terminated

Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0

FDA Recall Z-1023-04 · Posted 2004-07-20

Recalling FirmCAS Medical Systems, Inc.
Recall StatusTerminated
Product CodeBZQ
Date Initiated2004-05-24
Date Terminated2005-06-13
Product Quantity146 units

Reason for Recall

Device may not alarm for %SpO2 value limit violations if a specific feature is enabled

Firm Action

CAS Medical notified customers by telephone and followed with letter dated 5/24/04, advising users of the problem and to turn off the StatsSeconds feature.

Root Cause

Other

Distribution Pattern

CA, DC, IL, IN, GA, ME, MI, MN, NH, NJ, NY, PA, TX, WV. Foreign: Canada, Taiwan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962781COROMETRICS MODEL 510 AND 511 MONITORGe Medical Systems Information Technologies · 1997-03-06

Official Source

View FDA Recall →

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

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