Class 2 Device Recall Ultraview SL (UVSL) Command Module

• Date Initiated by Firm: April 12, 2023
• Date Posted: May 03, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1503-2023
• Recall Event ID: 91851
• 510(K)Number: K103142
• Product Classification: Detector and alarm, arrhythmia - Product Code DSI
• Product: Ultraview SL (UVSL) Command Module, Model 91496
• Code Information: Software version 2.03.06 and earlier and software version 2.04 and later.
• Recalling Firm/ Manufacturer: Spacelabs Healthcare, Inc.; 35301 Se Center St; Snoqualmie WA 98065-9216
• For Additional Information Contact: Zachary Orlowski ; 425-396-3300
• Manufacturer Reason for Recall: Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may cause clinicians to miss a potentially catastrophic event.
• FDA Determined Cause: Component change control
• Action: On 4/12/23 correction notices were sent and customers were provided the following information: In software versions up to and including version 2.03.06: "Processing Suspended" messaging overlays the waveforms, question marks (?) replace the typically found numerical data, and there is an "alarm off" symbol on the far right of the parameter zone while the product in in Suspend status. The patient s ECG and Respiratory waveforms remain displayed in the parameter zone of the user interface while the product is in Suspend status. In software version 2.04 and later, "Processing Suspended" messaging overlays the waveform zone, question marks (?) replace the typically found numerical data, and there is an "alarm off" symbol on the far right of the parameter zone while the product in in suspend status; however, the active patient waveforms are no longer displayed. We believe that the halted display of parameter waveforms more clearly communicate that the product is in Suspend status. The recalling firm recommends: 1) All users must be adequately trained on all versions of the product that will be used. 2) Ensure that all users are aware that Suspend Processing status means that all parameter processing and alarms are stopped and will not function. 2) The Suspended state must be manually re-engaged by pressing the "Resume Processing" button to return to active processing and return the alarms to the intended operation. 3) Please pass this notice on to those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 4) All customers should acknowledge receipt and understanding of the notice at the following URL: https://spacelabshealthcare.com/support/recall-reply-form/2023-00001-c/ Questions regarding this correction can be directed to Technical Support at 1-800-522-7025, select option 2.
• Quantity in Commerce: 1,088
• Distribution: US Nationwide distribution in the states of SD, KY, MO, WA, OH, NC, CA, OR, TX, GA, IL, OK, SC, PA, AL, KS, FL, ID, MI, MN, IA, NJ, MD, VA, AR, CT, NE, LA, AK, MS, ME, WV, NY, AZ, TN, WY, IN, MA, MT, CO, DE, ND, WI, NV, RI, NH, UT.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DSI and Original Applicant = SPACELABS HEALTHCARE, INC.