Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, low Sp02 message, event mark. Measuring range Sp02 0 to 100, pulse rate 20 to 250, measuring accuracy Sp02 +/-2% (70 to 100), pulse rate +/- 2, Sp02 alarm, audible and visible, probe type finger, multi-site, paitent range adult to neonatal, memory function approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hrs, size 42x68x20mm, weight 42g.
- Company
- Minolta Corp
- Recall Initiated
- November 14, 2003
- Posted
- July 20, 2004
- Terminated
- April 14, 2004
- Recall Number
- Z-0290-04
- Quantity
- 9
- Firm Location
- Ramsey, NJ
Reason for Recall
Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.
Distribution
The units were shipped to one distributor in Utah.
Lot / Code Info
Model 3iA, Serial Nos.: 23001201; 23001204; 23001206; 23001210; 23001212-23001214; 23001216; 23001217.
Root Cause
Other
Action Taken
Distributor provided customer list to Konica Minolta who initiated phone calls to the customers on 11/14/2003.