Recall Z-1503-2023 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Healthcare, Inc.
Ultraview SL (UVSL) Command Module, Model 91496
| Date | May 3, 2023 (initiated Apr 12, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Component change control |
| Action | 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" messagi |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103142 | SPACELABS MULTI-PARAMETER MODULE Spacelabs Healthcare, Inc., Mar 3, 2011 |