Reported Feb 5, 2014 · Terminated
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or…
Spacelabs Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spacelabs Healthcare, Llc · 35301 Se Center St · Snoqualmie, WA · 98065-9216
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Numbers IN the US
988 of 988 codes
6281- 0020026281- 0020036281- 0020046281- 0020056281- 0020066281- 0020076281- 0020086281- 0020096281- 0020106281- 0020116281- 0020126281- 0020136281-0002956281-0004016281-0004026281-0004036281-0004046281-0004056281-0004066281-0004076281-0004086281-0005036281-0005046281-0005056281-0005066281-0005076281-0005086281-0005126281-0005136281-0005146281-0005156281-0005166281-0005176281-0005186281-0005196281-0005206281-0005216281-0005226281-0005236281-0005246281-0005266281-0005276281-0005286281-0005296281-0005306281-0005316281-0005326281-0005336281-0005346281-0005356281-0005366281-0005376281-0005386281-0005396281-0005406281-0005416281-0005426281-0005436281-0005446281-000545
- SERIAL NUMBERS OUTSIDE THE US6281-000451, 6281-000771, 6281-000772, 6281-000773, 6281-000774, 6281-000775, 6281-000776, 6281-000993, 6281-000994, 6281-000995, 6281-000996, 6281-000997, 6281-000998, 6281-000999, 6281-001000, 6281-001001, 6281-001002, 6281-001003, 6281-001004, 6281-001038, 6281-001039, 6281-001040, 6281-001041, 6281-001042, 6281-001043, 6281-001044, 6281-001045, 6281-001046, 6281-001047, 6281-001048, 6281-001049, 6281-001050, 6281-001051, 6281-001052, 6281-001053, 6281-001054, 6281-001055, 6281-001056, 6281-001057, 6281-001058, 6281-001059, 6281-001060, 6281-001061, 6281-001062, 6281-001063, 6281-001064, 6281-001065, 6281-001066, 6281-001067, 6281-001068, 6281-001069, 6281-001070, 6281-001071, 6281-001172, 6281-001173, 6281-001174, 6281-001175, 6281-001475, 6281-001476, 6281-001514, 6281-001515, 6281-001516, 6281-001517, 6281-001705, 6281-001706, 6281-001994, 6281-001995, 6281-001996, and 6281-001997. Spacelabs is currently conducting a internal audit and discovered that there are additional lot numbers for this recall. 6681-003056, 6281-002500, 6281-002501, 6281-002659, 6281-002661, 6281-002662, 6281-002663, and 6281-002664
- Serial Numbers IN the US
- Amount recalled
- 1057 units (988 in the US and 69 outside of the US).
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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