Spacelabs Ultraview SL Command Modules Recalled for Monitoring Suspension

Plain-English summary

Spacelabs Healthcare Inc is recalling Ultraview SL Command Modules, Model 91496-M, that were upgraded with the Masimo SpO2 Option. The recall involves 1,999 units, with 1,932 units distributed in the United States and 67 units distributed internationally, including in France.

The recall was initiated after customers reported that during a module reset, which lasts approximately 10 seconds, the monitoring of all clinical parameters is suspended. Upon completion of the reset sequence, alarms are reset to their default values. The affected modules are intended for use with the Patient Care Management System to monitor clinical parameters in adult or neonate/infant populations in clinical environments other than home use.

Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. The recall covers units distributed in specific US states and France. No specific consumer action is detailed in the source text beyond the identification of affected serial numbers.

The recalled product

Product

Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adul

Manufacturer

Spacelabs Healthcare Inc

Category

Medical Device — Patient Monitoring

Hazard

• monitoring-suspension
• alarm-reset

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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