Class 2 Device Recall Ultraview SL Command Modules, Model 91496M, upgraded with the Masimo SpO2 Option

• Date Initiated by Firm: April 17, 2015
• Date Posted: April 28, 2015
• Recall Status: Terminated on November 13, 2015
• Recall Number: Z-1542-2015
• Recall Event ID: 71074
• 510(K)Number: K103142
• Product Classification: Detector and alarm, arrhythmia - Product Code DSI
• 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 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 all information network for display, recording, editing and analysis.
• Code Information: SERIAL NUMBERS IN THE US: 1496-000473, 1496-000590, 1496-001126, 1496-001189, 1496-001214, 1496-001299, 1496-001300, 1496-001301, 1496-001302, 1496-001303, 1496-001304, 1496-001305, 1496-001306, 1496-001307, 1496-001309, 1496-001328, 1496-001329, 1496-001330, 1496-001332, 1496-001333, 1496-001335, 1496-001336, 1496-001337, 1496-001712, 1496-001713, 1496-001714, 1496-002442, 1496-002568, 1496-002691, 1496-002743, 1496-002832, 1496-002833, 1496-002834, 1496-002836, 1496-002837, 1496-002838, 1496-002839, 1496-002840, 1496-002841, 1496-002917, 1496-002918, 1496-002919, 1496-002920, 1496-002998, 1496-002999, 1496-003000, 1496-003001, 1496-003002, 1496-003003, 1496-003005, 1496-003006, 1496-003007, 1496-003021, 1496-003022, 1496-003025, 1496-003035, 1496-003036, 1496-003037, 1496-003042, 1496-003043, 1496-003044, 1496-003046, 1496-003049, 1496-003051, 1496-003055, 1496-003158, 1496-003161, 1496-003162, 1496-003163, 1496-003164, 1496-003179, 1496-003187, 1496-003190, 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1496-113952, 1496-113953, 1496-113954, 1496-113956, 1496-113957, 1496-113958, and 1496-113959.
• Recalling Firm/ Manufacturer: Spacelabs Healthcare Inc; 35301 SE Center St; Snoqualmie WA 98065-9216
• For Additional Information Contact: Technical Support; 800-522-7025 Ext. 2
• Manufacturer Reason for Recall: Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.
• FDA Determined Cause: Software design
• Action: Spacelabs Healthcare sent an Urgent - Medical Device Correction letter, dated 17 April 2015, to the US consignees via priority mail. On 4/24/2015, the firm will send the Urgent - Medical Device Correction letter (translated as necessary) via email to international subsidiaries and distributor of record. The Identified the affected product, problem and actions to be taken. Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M are affected. Ultraview SL Command Modules originally shipped with Masimo SpO2 are NOT affected. Spacelabs Healthcare will contact you to schedule a convenient time for Spacelabs to correct all of your facility's affected Command Modules at no cost. For additional information or technical assistance, please contact: Technical Support Spacelabs Healthcare, Inc. 35301 SE Center St. Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support
• Quantity in Commerce: 1999 units total (1932 in the US and 67 international)
• Distribution: Worldwide Distribution- US Nationwide in the states of AL, DE, GA, ID, IL, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, VA, WA and the country of France.
• 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 = DSI and Original Applicant = SPACELABS HEALTHCARE, INC.