Z-0290-04

Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, low Sp02...

Name: Z-0290-04 Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, low Sp02...
Creator: Minolta Corp
Published: 2003-11-14
License: https://open.fda.gov/license/

Minolta Corp / initiated 2003-11-14 / Terminated / root cause: software

FDA source

Minolta Corp began a recall of 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... on 2003-11-14. The reason FDA records is "Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0290-04
Status: Terminated
Initiated: 2003-11-14
Posted: 2004-07-20
Terminated: 2004-04-14
Recalling firm: Minolta Corp
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 approx. 48 hrs, size 42x68x20mm, weight 42g.
Product code: DQA Oximeter
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.
Root cause tag: software
FDA root cause: Other
Action: Distributor provided customer list to Konica Minolta who initiated phone calls to the customers on 11/14/2003.
Quantity in commerce: 9
Distribution: The units were shipped to one distributor in Utah.
Product codes and lots: Model 3iA, Serial Nos.: 23001201; 23001204; 23001206; 23001210; 23001212-23001214; 23001216; 23001217.

Product code DQA

K010413Class IIMinolta Pulsox-3Si, Pulsox-3Ia, Pulsox-3LiKonica Minolta Sensing, Inc. / cleared 2001-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)