Recall Z-2261-2020 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Inc.
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
| Date | Aug 30, 2019 |
| Status | Terminated |
| Reason | The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Urgent Medical Device Correction letters were sent to U.S. customers on August 30, 2019 via priority service, and to foreign customers via email on September 6, 2019. The letter informed customers of the conditions under which alarm audio may be lost, and actions the customer /user can take to minimize risk to patients or users. Customers were requested to weigh the benefits versus the risks when deciding whether or not to continue to use Xhibit Central with software versions 1.3.1, 1.3.2, 1.3.3, and 1.3.4. Customers experiencing a loss of audio were informed that a complete reboot of the X |
| Quantity | 2197 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122146 | XHIBIT CENTRAL STATION, MODEL 96102 Spacelabs Healthcare, Apr 22, 2013 |