Recall Z-0810-2025 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
| Date | Jan 7, 2025 (initiated Nov 25, 2024) |
| Status | Open, Classified |
| Reason | Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed. |
| Root cause | Software change control |
| Action | On 11/25/2024, correction notices were emailed to customers who were asked to do the following: Firm will contact you at the earliest possible date to schedule a convenient time to update affected devices to software version 1.4.2 for XTR systems which addresses this defect. You can also contact GTS to have an FSE paged out for discussing upgrade schedule: 1-800-522-7025 and select 2 for Technical Support. Complete and submit the customer acknowledgement form: https://spacelabshealthcare.com/support/recall-reply-form/recall-reply-form-xtr-15-nov-2024/ For additional information or technic |
| Quantity | 434 |
| Distribution | US: MN, TX, TN, SC, OK, NM, GA, PA, OH, IA, AL, CO, AR, FL, MO, ME, LA, IL, WA, MA, WI, OR, MS, ID, NY, KS, PR. OUS: Canada, Taiwan, Czech Republic, France, Greece, Italy, Kuwait, Philippines, Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141156 | SPACELABS HEALTHCARE TELEMETRY RECEIVER Spacelabs Healthcare, Sep 9, 2014 |