Recall Z-0871-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Llc
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
| Date | Jan 30, 2014 (initiated Dec 19, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 wil |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121480 | ARIATELE TELEMETRY TRANSMITTER (96281) Spacelabs Healthcare, Jun 6, 2012 |