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Ultraview SL (UVSL) Command Module, Model 91496 recallZ-1503-2023 · Spacelabs Healthcare, Inc. · initiated Apr 12, 2023

Class II Open, Classified All recalls posted in May 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Spacelabs Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Component change control

What the company is doing

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.

Recall details

Recall number
Z-1503-2023
Recall class
Class II
Status
Open, Classified
Initiated by the company
Apr 12, 2023
Posted by the FDA
May 3, 2023
Recalling firm
Spacelabs Healthcare, Inc.
Quantity
1,088
Product code
DSI
FDA submissions
K103142
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.

Product description

Ultraview SL (UVSL) Command Module, Model 91496

Code information (models, lots, serial numbers)

Software version 2.03.06 and earlier and software version 2.04 and later.

Other devices under the same FDA submission

2 devices cleared under K103142 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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