Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.
FDA Recall Z-0649-2010 · Posted 2010-01-19
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Recalling FirmSpacelabs Healthcare, Incorporated
Recall StatusTerminated
Product CodeDXJ
Date Initiated2009-11-06
Date Terminated2011-07-21
Product Quantity968 units
Reason for Recall
Potential for monitor to shut down and not being able to power on again.
Firm Action
On 11/6/09 the firm sent Urgent - Device Correction notifications to customers by certified mail informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. On 11/13/2009 the firm's Global Tech Support sent notification via email to all foreign subsidiaries and distributors informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. Questions are to be directed to Spacelabs Medical's Technical Support at 1-800-522-7025, and 1-425-657-7200 x5089 for those customers outside of the US.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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