Device Recall ARIATELE TELEMETRY TRANSMITTER, Model 96281 의 리콜

Recall

67243

Class 2

Z-0871-2014

2013-12-19

2014-01-30

Terminated

United States

2014-06-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125070

The ariatele model 96281 with spo2 monitoring option c is recalled because the ariatele (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.

On January 6, 2014, Spacelabs sent an "URGENT - MEDICAL DEVICE CORRECTION Spacelabs Healthcare AriaTele Model 96281 with SpO2 Option C" letter, dated 03 January 2014 to US consignees. On January 9, 2014, Spacelabs e-mailed the "URGENT - MEDICAL DEVICE CORRECTION Spacelabs Healthcare AriaTele Model 96281 with SpO2 Option C" letter (translated as necessary), dated 03 January 2014, to foreign consignees. The letter described product, problem and actions to be taken. The Consignees where instructed to follow the "Advise on what action the clinician takes" on the letter. Spacelabs Healthcare will contact you at the earliest possible date to schedule a convenient tie for Spacelabs to correct all of your facility's affected transmitters (software update) at no cost. 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.