ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or ne

FDA device recall Z-0871-2014 · posted 2014-01-30 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare, Llc

Reason for recall

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

MHX

Quantity affected

1057 units (988 in the US and 69 outside of the US).

Distribution

Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, GA, IA, IL, LA, MA, ME, MI, MO, MS, NY, PA, SC, TN, TX, VA, and Puerto Rico; and Internationally to: Canada, Chile, and Panama.

Date initiated

2013-12-19

Date posted

2014-01-30

Date terminated

2014-06-12

Location

Snoqualmie, WA

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