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
