Recall Z-0289-04 ยท DQA Oximeter
Minolta Corp
Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger, multi-site, Patient range adult to neonatal, memory function Approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optiona
| 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 | 291 |
| 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 |