Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.
- Company
- Spacelabs Healthcare, Inc.
- Recall Initiated
- January 17, 2018
- Posted
- January 25, 2018
- Terminated
- November 29, 2018
- Recall Number
- Z-0532-2018
- Quantity
- 12 systems
- Firm Location
- Snoqualmie, WA
Reason for Recall
Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
Distribution
US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France
Lot / Code Info
Serial numbers: 6280-000359, 6280-000340, 6280-000336, 6280-000503, 6280-000502, 6280-000500, 6280-000496, 6280-000495, 6280-000327, 6280-000260, 6280-000566, 6280-000290
Root Cause
Under Investigation by firm
Action Taken
On January , 2018, a customer letter was sent via priority service, return receipt requested, to all U.S. customers. International consignees will be notified on January 24 , 2018, by email. The letter stated: " Please weigh the benefits versus the risks when deciding whether or not to continue to use your Exhibit Telemetry Receiver(s) until updated as set forth below. We recommend that you brief your staff regarding the failure mode listed above." Spacelabs Healthcare will contact you to schedule a convenient time for Spacelabs to update your Exhibit Telemetry Receiver(s) to software version 1.0.2 at no cost." For further questions, please call (800) 522-7025.