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U.S. Department of Health and Human Services

Class 2 Device Recall ARIATELE TELEMETRY TRANSMITTER, Model 96281

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  Class 2 Device Recall ARIATELE TELEMETRY TRANSMITTER, Model 96281 see related information
Date Initiated by Firm July 02, 2014
Date Posted September 04, 2014
Recall Status1 Terminated 3 on October 16, 2014
Recall Number Z-2586-2014
Recall Event ID 69125
510(K)Number K121480  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
Code Information 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.  
Recalling Firm/
Spacelabs Healthcare Inc
35301 SE Center St
Snoqualmie WA 98065-9216
For Additional Information Contact Technical Support
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = SPACELABS HEALTHCARE