Z-1503-2023 Class II Ongoing
FDA device recall Z-1503-2023 was initiated by Spacelabs Healthcare, Inc. on April 12, 2023 and is designated Class II. 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 w… The recall status is ongoing. Affected quantity: 1,088.
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2023
- Initiation Date
- April 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,088
Product Description
Ultraview SL (UVSL) Command Module, Model 91496
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 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.
Code Information
Software version 2.03.06 and earlier and software version 2.04 and later.