FDA Medical Device Recalls (openFDA)
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 approx. 48 hrs, size 42x68x20mm, weight 42g.
- Recall number
- Z-0290-04
- 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.
- Status
- Terminated
- Initiated
- 2003-11-14
- Posted
- 2004-07-20
- Terminated
- 2004-04-14
- 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.
- Lot, serial or model codes
- Model 3iA, Serial Nos.: 23001201; 23001204; 23001206; 23001210; 23001212-23001214; 23001216; 23001217.
- 510(k) numbers
- ["K010413"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 1000136179
- Firm city
- Ramsey
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28