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/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hours, size: 42x68x20mm, weight 42g.
- Company
- Minolta Corp
- Recall Initiated
- November 14, 2003
- Posted
- July 20, 2004
- Terminated
- April 14, 2004
- Recall Number
- Z-0289-04
- Quantity
- 291
- Firm Location
- Ramsey, NJ
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.
Distribution
The units were shipped to one distributor in Utah.
Lot / Code Info
Model 3Si, Serial Nos: 22001453-22001469; 22001471-22001512; 22001514-22001599; 22001600-22001626; 22001628-22001632; 22001635-22001643; 22001645-22001651; 22001653-22001659; 22001661-22001676; 22001678-22001683; 22001685-22001686; 22001688-22001691; 22001712-22001714; 22001717-22001719; 22001721-22001723; 22001725; 22001727-22001732; 22001734-22001737; 22001740-22001745; 22001747-22001765; 22001767-22001770; 22001772; 22001776; 22001860; 22001862; 22001865; 22001868; 22001879; 22001881; 22001882; 22001885; 22001887; 22001893; 22001897; 22001899; 22001905.
Root Cause
Other
Action Taken
Distributor provided customer list to Konica Minolta who initiated phone calls to the customers on 11/14/2003.