Spacelabs Healthcare, Incorporated Spacelabs Model 91367 SL 2200 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential for monitor to shut down and not being able to power on again.

Recommended Action

Per FDA guidance

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.