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Terminated

Spacelabs flat panel monitor, Model 91415-A

FDA Recall Z-0269-04 · Posted 2004-07-20

Recalling FirmDatex-Ohmeda, Inc.
Recall StatusTerminated
Product CodeDXJ
Date Initiated2003-10-29
Date Terminated2004-09-17
Product Quantity2734 units for domestic consignees and 1099 for international consignees

Reason for Recall

Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.

Firm Action

A letter dated October 31, 2003 was sent on October 29-31, 2003 to all US customers via FED-EX. An ORDER FORM accompanied the letter for consignees to request a replacement power supply or to indicate they did not have the affected power supply.

Root Cause

Other

Distribution Pattern

The firm distributes to hospitals nationwide. The firm also distributes internationally.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932724SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAYSpacelabs Medical, Inc. · 1993-11-05

Official Source

View FDA Recall →

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

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