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

Vital Sign elance Monitor, Model 93300 Spacelabs Healthcare, Llc. A vital signs patient monitor with arrhythmia detection.

FDA Recall Z-2916-2011 · Posted 2011-08-02

Recalling FirmSpacelabs Healthcare, Llc
Recall StatusTerminated
Product CodeMHX
Date Initiated2011-07-06
Date Terminated2012-01-25
Product Quantity1970 units

Reason for Recall

Model 93300 Vital Signs Monitor may stop operating while in use, and when this occurs, the monitor may also fail to power ON. The resulting situation may cause a loss of monitoring for the patient.

Firm Action

Spacelabs Healthcare, Llc sent an "Urgent-Medical Device Correction" letter dated 18 July 2011 to all affected customers. The letter notified the customers of the problem and recommended customers make their staff aware. It also informed them a Field Service Engineer will contact them to check, and if necessary make adjustments. Customers can contact Spacelabs Healthcare at 800-522-7025 and select 2 for Technical Support or outside the U.S. at +86512-8717-1888, extension 304.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution: (USA) Nationwide distribution including the state of WI, and the countries of Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Chile, China, Colombia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Malaysia, Napel, Netherlands, Nicaragua, Oman, Palestine, Panama, Paraguay, Peru, Philippines, Republic of Macedonia, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, Venezuela, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093501ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONSpacelabs Medical, Inc. · 2009-11-24

Official Source

View FDA Recall →

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

↑