Recall Z-1513-2022 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model: 96280
| Date | May 31, 2022 |
| Status | Open, Classified |
| Reason | Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure. |
| Root cause | Software Design Change |
| Action | On 05/31/22, correction notices were mailed to customers who were asked to take the following actions that can be taken to minimize risk to patients or users: Weigh the benefits versus the risks when deciding whether to continue to use the alarm escalation feature within XTR 1.4. Suggestions from Spacelabs to mitigate the risk: - Set the priority to the same level as the escalation max on the product. This will ensure that the highest priority alarm is triggered for the technical alarm. - Do not run the XTR 1.4 for more than 24 days consecutively. Restarting the XTR after 24 days will miti |
| Quantity | 529 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of NY, AR, CO, FL, NJ, AL, KY, TN, SC, WA, OK, MN, PA, GA, VA, CA, OH, IA, KS, MI, IN, TX, MT, MO, ME, LA, IL, SD, MA, OR, ID, MD, AZ, AK and the countries of MB, ON, FR, QC, BC, IS, CT, RM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141156 | SPACELABS HEALTHCARE TELEMETRY RECEIVER Spacelabs Healthcare, Sep 9, 2014 |