Company: Spacelabs Healthcare, Inc
Date of Enforcement Report: 4/12/2023
Class II

PRODUCT

Ultraview SL (UVSL) Command Module, Model 91496

Recall Number:

Z-1503-2023

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Spacelabs Healthcare, Inc

VOLUME OF PRODUCT 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