Z-0532-2018Class II

Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient...

Name: Z-0532-2018 Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient...
Creator: Spacelabs Healthcare Inc
Published: 2018-01-17
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-01-17 / Terminated

FDA source

Spacelabs Healthcare Inc began a recall of Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The... on 2018-01-17. FDA classified it as Class II and gives the reason as "Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0532-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-17
Posted: 2018-01-25
Terminated: 2018-11-29
Recalling firm: GE Healthcare
Product: 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.
Product code: MSX System, Network And Communication, Physiological Monitors
Reason for recall: Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 12 systems
Distribution: US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0532-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0532-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-05

Product code MSX

K141156Class IISpacelabs Healthcare Telemetry ReceiverSpacelabs Healthcare / cleared 2014-09-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)