Company:Minolta Corp.
Date of Enforcement Report: 1/14/04
Class: II
PRODUCT
a) 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. Recall # Z-0289-04;
b) 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 # Z-0290-04.
REASON
Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.
CODE
a) 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.
b) Model 3iA, Serial Nos.: 23001201; 23001204; 23001206;
23001210; 23001212-23001214; 23001216; 23001217.
RECALLING FIRM/MANUFACTURER
Minolta Corp., Ramsey, NJ, by telephone on November 14, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
300.
DISTRIBUTION
UT.
