Recall Z-0290-04 ยท DQA Oximeter
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
| Date | Jul 20, 2004 (initiated Nov 14, 2003) |
| Status | Terminated |
| Reason | Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts. |
| Root cause | Other |
| Action | Distributor provided customer list to Konica Minolta who initiated phone calls to the customers on 11/14/2003. |
| Quantity | 9 |
| Distribution | The units were shipped to one distributor in Utah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010413 | MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI Konica Minolta Sensing, Inc., Aug 2, 2001 |