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Terminated

Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659.

FDA Recall Z-2232-2009 · Posted 2009-09-21

Recalling FirmOridion Medical 1987 Ltd.
Recall StatusTerminated
Product CodeCCK
Date Initiated2009-06-30
Date Terminated2010-10-01
Product Quantity326 units

Reason for Recall

1) The monitor's ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze. 2) The unit generates electromagnetic radiation above the limits set by applicable standards for medical devices

Firm Action

Oridian sent a letter to all its distributors June 25, 2009, instructing them to gather all the units to be exchanged for factory reconditioned units that have the hardware and software enhancements and meet all performance requirements in full.

Root Cause

Device Design

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060065CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOROridion Capnography, Inc. · 2006-05-04

Official Source

View FDA Recall →

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

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