Z-2586-2014Class II

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a...

Name: Z-2586-2014 ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a...
Creator: Spacelabs Healthcare Inc
Published: 2014-07-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-07-02 / Terminated / root cause: software

FDA source

Spacelabs Healthcare Inc began a recall of ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment on 2014-07-02. FDA classified it as Class II and gives the reason as "The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2586-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-02
Posted: 2014-09-04
Terminated: 2014-10-16
Recalling firm: GE Healthcare
Product: ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.
Root cause tag: software
FDA root cause: Software design
Action: Spacelabs notified both consignees via email of the expanded recall July 2, 2014. A f/u letter was sent by overnight delivery to the single new consignee the same day. Spacelabs sent an announcement of the expanded recall to both consignees identified in the expanded recall August 25, 2014. A field service technician from Spacelabs will visit each consignee and upgrade the software as necessary. If you have any questions about this corrective action program, please contact SpaceLabs Healthcare at 1-800- 522-7025, and select 2 for Technical Support.
Quantity in commerce: 8 units
Distribution: US Distribution to TX.
Product codes and lots: Serial numbers: 6281-002500, 6281-002501, 6281-002659, 6281-002661, 6281-002662, 6281-002663, 6281-002664, and 6281-003056. Model 96281, with SpO2 Option C.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2586-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2586-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-04

Product code MHX

K121480Class IIAriatele Telemetry Transmitter (96281)Spacelabs Healthcare / cleared 2012-06-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)