Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with a
FDA device recall Z-0532-2018 · posted 2018-01-25 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare Inc
- Reason for recall
- Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MSX
- Quantity affected
- 12 systems
- Distribution
- US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France
- Date initiated
- 2018-01-17
- Date posted
- 2018-01-25
- Date terminated
- 2018-11-29
- Location
- Snoqualmie, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS HEALTHCARE TELEMETRY RECEIVER (K141156) | Spacelabs Healthcare | 2014-09-09 |