Spacelabs Healthcare, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1503-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Ultraview SL (UVSL) Command Module, Model 91496

Product Classification:

Class II

Date Initiated: April 12, 2023

Date Posted: May 10, 2023

Recall Number: Z-1503-2023

Event ID: 91851

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.

Status: Ongoing

Product Quantity: 1,088

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated