Recall Z-1502-2016 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare Inc
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
| Date | Mar 28, 2016 |
| Status | Terminated |
| Reason | Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), which is indicative of the loss of the telemetry data signal. In some cases, the Xhibit Central Monitor was also reported to display an Xhibit Offline error message for all patients being monitored. |
| Root cause | Other |
| Action | On March 28, 2016, a customer letter will be sent via priority service, return receipt requested, to all U.S. customers. On April 4, 2016, a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Spacelabs recommends that you brief your staff regarding the failure modes listed above. If you continue to use affected Telemetry Receiver(s), please note: **When there is a loss of signal, a signal loss alarm is generated and a triangular-shaped squelch waveform is displayed for any channel exhibiting signal loss. If unacknowle |
| Quantity | 217 units of XTRs and 531 units of PCBAs (164 XTRs and 425 PCBAs in US and 53 XTRs and 106 PCBAs outside the US) |
| Distribution | distributed in AL, AZ, CA, CO, CT, FL, ID, IN, KY, MI, MN, MO, MS, MT, SC, TX, WY and in the following countries: AUSTRALIA, CANADA, CHINA, FRANCE, NETHERLANDS, PHILIPPINES, ROMANIA, and UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141156 | SPACELABS HEALTHCARE TELEMETRY RECEIVER Spacelabs Healthcare, Sep 9, 2014 |