Class 2 Device Recall Vital Signs Monitor, Model 93300

• Date Initiated by Firm: September 23, 2010
• Date Posted: August 15, 2011
• Recall Status: Terminated on August 17, 2011
• Recall Number: Z-3024-2011
• Recall Event ID: 56839
• 510(K)Number: K093501
• Product Classification: Monitor, physiological, patient (with arrhythmia detection or alarms) - Product Code MHX
• Product: Spacelabs Medical elance Vital Signs Monitor, Model 93300.; ; The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in all areas of a healthcare facility. It is indicated for use in adult and pediatric populations. The device facilitates the monitoring of: ECG with arrhythmia detection; respiration; non-invasive blood pressures; invasive blood pressures; body temperature; functional arterial oxygen saturation; and entidal CO2.
• Code Information: Model 93300. 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93300-100049, 93300-100050, 93300-100053, 93300-100054, 93300-100062, 93300-100063, 93300-100064, 93300-100067, 93300-100068, 93300-100070, 93300-100073, 93300-100074, 93300-100075, 93300-100076, 93300-100077, 93300-100080, 93300-100081, 93300-100084, 93300-100085, 93300-100090, 93300-100092, 93300-100096, 93300-100097, 93300-100100, 93300-100104, 93300-100105, 93300-100106, 93300-100107, 93300-100108, 93300-100109, 93300-100110, 93300-100111, 93300-100112, 93300-100113, 93300-100114, 93300-100115, 93300-100116, 93300-100117, 93300-100118, 93300-100120, 93300-100121, 93300-100122, 93300-100123, 93300-100124, 93300-100125, 93300-100126, 93300-100127, 93300-100128, 93300-100129, 93300-100130, 93300-100131, 93300-100132, 93300-100133, 93300-100258, 93300-100259, 93300-100263, AND 93300-100265.
• Recalling Firm/ Manufacturer: Spacelabs Healthcare, Llc; 5150 220th Ave Se; Issaquah WA 98029-6834
• For Additional Information Contact: Al Van Houdt; 425-657-7200 Ext. 5970
• Manufacturer Reason for Recall: The monitor has a 3 second delay in the waveforms and respiration alarm; the delay is not disclosed in the IFU.
• FDA Determined Cause: Error in labeling
• Action: Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated September 24, 2010 to all affected customers. The letter describes the product, problem, and the action to be taken. The letter includes the revised Operator's Manual as a replacement for customers current manual. For Technical Support call Spacelabs Medical at 1-800-522-7025 and select 2.
• Quantity in Commerce: 2517
• Distribution: Worldwide Distribution-USA (Puerto Rico) and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KENYA, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MACEDONIA, MALAYSIA, NEPAL, NETHERLANDS, NICARAGUA, OMAN, PALESTINE, PANAMA, PARAGUAY, PERU, PUERTO RICO, PHILIPPINES, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MHX and Original Applicant = SPACELABS MEDICAL INC.