Ultraview SL (UVSL) Command Module, Model 91496
- Company
- Spacelabs Healthcare, Inc.
- Recall Initiated
- April 12, 2023
- Posted
- May 3, 2023
- Recall Number
- Z-1503-2023
- Quantity
- 1,088
- Firm Location
- Snoqualmie, WA
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.
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.
Lot / Code Info
Software version 2.03.06 and earlier and software version 2.04 and later.
Root Cause
Component change control
Action Taken
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.