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Terminated

Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. 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 adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.

FDA Recall Z-0690-2012 · Posted 2012-01-11

Recall StatusTerminated
Product CodeDSI
Date Initiated2011-11-03
Date Terminated2012-09-19
Product Quantity6722 units worldwide (3598 units in US and 3124 units outside US)

Reason for Recall

NIBP pump inside the Ultraview SL Command Module, Model 91496, became loose. The pump is suspended by the air hoses and electrical connections, but there can be enough movement to damage internal components and cause the module to fail.

Firm Action

SpaceLabs Healthcare sent a Urgent Field Safety Notice dated November 28, 2011, return receipt requested to all US customers. The letter identified the product the problem and the action needed to be taken by customer. On December 6, 2011, SpaceLabs will send a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Records of notification will be maintained to ensure complete notification. Customers were instructed If you hear an unusual rattling noise, tag the module, set it aside and contact your Spacelabs field service engineer. Your field service engineer will be contacting you early in 2012 to schedule a mutually agreeable time to upgrade all of your affected modules. Upgrades will be performed on-site and at no cost to you. For any questions about this corrective action program, please call Spacelabs Medical at 1-800-522-7025 and select 2 for Technical Support or, outside the United States, 1-425-657-7200 x5089.

Root Cause

Process change control

Distribution Pattern

Worldwide Distribution -- USA (nationwide)

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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