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Terminated

Datex-Ohmeda Cardiocap/5 Patient Monitors

FDA Recall Z-0143-04 · Posted 2004-07-20

Recalling FirmDatex-Ohmeda Inc
Recall StatusTerminated
Product CodeMHX
Date Initiated2003-10-17
Date Terminated2005-11-15
Product Quantity875 units

Reason for Recall

Datex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.

Firm Action

Recall letters dated October 15, 2003 were sent to the consignees on 10/17/03. The letters request that the consignees order service kits to correct the units and use the kits to make the corrections of the devices.

Root Cause

Other

Distribution Pattern

The monitors were shipped to consignees located nationwide in the United States and to foreign consignees located worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012837MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIESDatex-Ohmeda · 2001-09-14K992323DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIESDatex-Ohmeda, Inc. · 1999-11-01

Official Source

View FDA Recall →

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

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