Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor.

FDA Recall Z-0523-2007 · Posted 2007-02-27

Recalling FirmSpacelabs Healthcare, Incorporated
Recall StatusTerminated
Product CodeDSI
Date Initiated2007-01-03
Date Terminated2011-02-15
Product Quantity1347 devices; 1067 domestic and 280 international

Reason for Recall

Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and Sp02 alarm limits being frozen. This can result in delay in treatment.

Firm Action

On 1/3/07 the firm issued a letter to their customers advising of the issues and provided guidance to the consignee to enable the Check Setup feature that will provide an audible prompt whenever the monitor resets. The letter advises that consignees will be contacted to schedule an update, once new software has been validated.

Root Cause

Other

Distribution Pattern

Nationwide and worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050605SPACELABS MEDICAL MULTIPARAMETER MODULE 91496Spacelabs Medical, Inc. · 2005-05-03

Official Source

View FDA Recall →

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

↑