Minolta Corp 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 app Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 app
Brand
Minolta Corp
Lot Codes / Batch Numbers
Model 3iA, Serial Nos.: 23001201, 23001204, 23001206, 23001210, 23001212-23001214, 23001216, 23001217.
Products Sold
Model 3iA, Serial Nos.: 23001201; 23001204; 23001206; 23001210; 23001212-23001214; 23001216; 23001217.
Minolta Corp is recalling Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, due to Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.
Recommended Action
Per FDA guidance
Distributor provided customer list to Konica Minolta who initiated phone calls to the customers on 11/14/2003.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, UT
Page updated: Jan 10, 2026